World Biosimilars Conference

Biosimilar 2018

Theme: New innovations in Biosimilars

Meetings International is pleased to welcome every one of the members from everywhere throughout the world to go to the esteemed International Conference on biosimilars (World Biosimilars Conference ) booked amid August 20-21, 2018 in Chicago, USA. We are certain that you will appreciate the Scientific Program of this upcoming Conference. This worldwide gathering incorporates keynote introductions, Oral talks, workshops, symposium, Poster introductions, and Exhibitions.

Meetings International (Meetings Int.) is a worldwide pioneer in creating top-notch gatherings, workshops, and symposia in every real field of science, innovation, and medication. Since its commencement, Meetings Int. has been related to national and universal affiliations, enterprises committed to having world-class gatherings and occasions. Gatherings Int. underpins expansive extension research and associate audit at a wide scope of experts around the globe.

Why to attend:

World biosimilars conference unites a one of a kind and International blend of specialists, scientists, researchers, IPR professionals, CROs and CMOs from around the world both from the scholarly world and industry over the globe to trade their insight, experience and research advancements in a single stage. This is the best chance to achieve the biggest array of members of the senior officials from the Generic and biosimilar industry to give new experiences, future market patterns, creative business techniques and open doors for development for Pharmaceutical Industry group. Widely acclaimed speakers, the latest systems, improvements, and the most up to date refreshes in Biosimilars and Biologics are signs of this gathering. This Platform gives a one of a kind gathering to nonexclusive pharmaceutical officials from around the globe to arrange and hears incredibly famous specialists talking about the most recent knowledge into the universal business, legitimate, and administrative advancements concerning the nonspecific pharmaceutical part.

Dear All,

It is a great pleasure for us to welcome you to the “World Biosimilars Conference” which will be held during August 20^th - 21^st, 2018 in Chicago.

We have come a long way from botanicals to chemicals to biologics—and now now the biosimilars that are developed using a scientific, not empirical approach—how these two different makes all the difference. Let us examine the contemporary science and technology that is helping us bring these lifesaving drugs more accessible.

Thanks and Regards.

Sarfaraz K. Niazi, Ph.D., SI, FPAMS, FACB, FRSB

Executive Chairman, Karyo Biologics, LLC and Pharmaceutical Scientist Inc.

Adjunct Professor of Biopharmaceutical Sciences, University of Illinois

Biosimilars- Hatch-Waxman Act & BPCI Act: Hatch- Waxman act is the alteration to Federal, Food, Drug and Cosmetics Act which built up the cutting edge arrangement of endorsement of generics through Abbreviated New Drug Applications (ANDAs). The Patient Protection and Affordable Care Act (PPAC Act) was marked into law in March 2010 despite the modifications in the Public Health Service Act (PHS Act) to make a contracted endorsement pathway for biosimilars and take after on biologics. These new statutory arrangements are regularly called as the Biologics Price Competition and Innovation Act of 2009 (BPCI Act). This track concentrates upon such legitimate ties and the parts of the BPCI Act that relate to the biosimilars and biologics.

Related conferences: European Biosimilars Congress, April 26-27, 2018 Rome, Italy; 13th International Conference on Biologics and Biosimilars October 24-25, 2018 Boston, USA; 9th Asian Biologics and Biosimilars Congress August 20-21, 2018 Tokyo, Japan; International Conference & Exhibition on Biologics and Biosimilars Orlando, Florida, USA; Biologics & Biosimilars Congress, March 26-27, 2018, Berlin, Germany.

Challenges in Developing Biosimilars: With a normal $67 billion worth of licenses on natural items ending before 2020 and governments constrained to decrease quickly rising human services costs, biosimilars speak to a noteworthy open door for the pharmaceutical business. Biosimilars are exceedingly like their authorized reference item notwithstanding minor complexities as excipients in the definition; furthermore, there are no amazing contrasts between the biologicals and the reference item as far as wellbeing, virtue, and intensity. In any case, there are sure difficulties in the method for its progression and accepting a green banner for impelling into the market.

Current Developments in the Field of Biosimilars: Biologic therapeutic products created through rDNA technology as recombinant protein-based medicines that have been in clinical use since the early 1980s as original biopharmaceuticals have greatly contributed to the therapy of severe metabolic and degenerative diseases. The recent expiration of the data protection or patents for most of them created opportunities for the development of copy versions of original biopharmaceuticals with similar biologic activity (termed biosimilars). Production of these new products is expected to meet worldwide demand, promote market competition, maintain the incentives for innovation, and sustain the healthcare systems.

Emerging Trends in Biosimilars: As licenses of the at first introduced organic therapeutics in oncology have begun to slip by, contending pharmaceutical organizations are permitted to create and showcase an indistinguishable protein from the originator operator. Particularly in the field of oncology, the presentation of monoclonal antibodies has brought about dynamite helpful advances by expanding the cure rate of early growths and drawing out survival. Comparable advances have happened in rheumatology, hematology, neurology and diverse fields. The viability of granulocyte state fortifying variable (G-CSF; filgrastim) biosimilars has been evaluated regarding engraftment following foundational microorganism transplantation.

Cost Analysis of Biosimilars: This track is concentrated towards the distinctive audits and conjectures with respect to the scenario of Biosimilars advertise and take after on Biologics. The present status and future situation of the market are best to be talked about amid this session. The market looks into from the principal propelling of biosimilar to the freshest one till date prospects for a radical change in the pharmaceutical market. Economic specialists, showcase investigators, industrialists would be the able members for this session at World Biosimilars Congress.

Clinical Studies on Biosimilars: In inventive medication advancement, three stages, and normally different investigations per stage, of clinical research are required. Interestingly, biosimilar clinical improvement can be shortened due to the broadness of comprehension of the reference biologic and if the auxiliary or practical comparability of the biosimilar has been to begin with showed diagnostically. While clinical prerequisites vary by administrative office, all in all, two periods of clinical examinations are required – a Phase I concentrate to exhibit comparable pharmacokinetics (how a pharmaceutical travels through the body) and a Phase II investigation of pharmacodynamics (impact of the prescription in the body), alongside an essential report, alluded to as Phase III, to show comparative viability, wellbeing and immunogenicity to the reference biologics.

Innovative Approach for Biosimilars: Biosimilars are authoritatively affirmed "imaginative" adaptations of unique items, and can be made when the first item's patent lapses. A total of 41 new molecular entities (NMEs) and biologics (BLAs) were approved by the FDA in 2014 - 15 of those were approved in December alone (11 in final two weeks. The U.S. Food and Drug Administration approved Mvasi (bevacizumab-awwb, Which is the first biosimilar approved by the USA for cancer) as a biosimilar to Avastin (bevacizumab) for the treatment of multiple types of cancer on September 14, 2017.This session additionally discovers put for all the biosimilar exhibitors related to the field of biosimilar and biologics.

Consequences of Brexit on Biosimilars: Brexit will have many consequences for the pharmaceutical industry, including EMA location; effect of UK marketing authorizations from both a regulatory and IP (i.e., SPC) standpoint, impact on pharmaceutical patents in the context of the Unitary Patent (UP) and the Unified Patent Court (UPC), loss of influence from the UK in the context of future EU legislative developments.

Biosimilars Market- Challenges & Prospects

Biosimilar Industry faces many challenges, which includes:

High development cost: Developing a biosimilar is not a simple process but one that requires significant investment, technical capability and clinical trial expertise. Average cost estimates range from US$ 100 to 250 million (various industry sources) if plant development is included (or US$ 20 to 100 million for non-plant cost).
Fledgling regulatory framework: In most markets apart from Europe, the regulatory framework for biosimilars is generally still very new compared to the well- established approval process for NCEs and small-molecule generics; in some cases it is non-existent, making global investments risky.
Manufacturing issues: The development of biosimilars involves sophisticated technologies and processes, raising the risk of the investment.

Globalization of Biosimilars: This track discusses the nonexclusive medications effect on worldwide biosimilar market and Cost and hazard administration, Adopting imaginative instruments, for example, chance sharing the course of action, European market for biosimilars.

The individuals who can go to the biosimilars meeting under this track are ones after Biologics/Proteins/Biosimilars Products, New Biosimilars Development, Process Science, Biosimilars Market, Portfolio Management, Research and Development, Business Development, Business Operations and Scientific Affairs.

Intellectual Property Rights: IPR is of prime importance in the field of biologics and biosimilars. Most scientist and industries tend to retain their monopoly business by exercising the IPR.

The very name Biosimilars calls for the occurrence of Intellectual Property rights laws and by-laws. Hence this session is of utmost interest to the attorneys and law personnel. Currently, the US provides 12 years of exclusivity for new biological products under the Biologics Price Competition and Innovation Act (BPCIA).The provision providing 12 years exclusivity was buried inside the 20,000-page healthcare law. Eight years of exclusivity would keep biologic medicines out of the hands of many who need them. Prices frequently exceed $100,000.

US-FDA Approved Biosimilars: In the United States, the Food and Drug Administration (FDA) held that new legislation was required to enable them to approve biosimilars to those biologics originally approved through the PHS Act pathway. Since 2004 the FDA has held a series of public meetings on biosimilars.

The FDA has previously approved biologic products using comparability, for example, Omnitrope in May 2006, but this like Enoxaparin was also to a reference product, Genotropin originally approved as a biologic drug under the FD&C Act.

On March 6, 2015, Zarxio obtained the first approval of FDA. Sandoz’s Zarxio is biosimilar to Amgen’s Neupogen (filgrastim), the first product to be passed under the Biologics Price Competition and Innovation Act of 2009 (BPCI Act), which was passed as part of the Affordable Healthcare Act. But Zarxio was approved as a biosimilar, not as an interchangeable product, the FDA notes. And under the BPCI Act, only a biologic that has been approved as an “interchangeable” may be substituted for the reference product without the intervention of the healthcare provider who prescribed the reference product.

Biosimilars Approved in Europe: Biosimilars have been broadly and securely utilized as a part of Europe since 2006. In 2004, the European Commission (EC) passed enactment making a biosimilars endorsement pathway (Directive 2001/83/EC Directive 2004/27/EC). In 2005 and 2006, the European Medicines Agency (EMA) discharged its first arrangement of biosimilar rules, and in 2006, endorsed its first biosimilar. To date, there have been 14 biosimilars approved, with biosimilar monoclonal antibodies expected soon. In spite of a thorough observing, following, and following framework, Europe has distinguished no security issues with biosimilars.

Related Conferences:European Biosimilars Congress, April 26-27, 2018 Rome, Italy; 13th International Conference on Biologics and Biosimilars October 24-25, 2018 Boston, USA; 9th Asian Biologics and Biosimilars Congress August 20-21, 2018 Tokyo, Japan; International Conference & Exhibition on Biologics and Biosimilars Orlando, Florida, USA; Biologics & Biosimilars Congress, March 26-27, 2018, Berlin, Germany.

Biosimilars in Cancer Therapy: Biosimilars have potential advantages in the treatment of cancer, as they introduce competition into the drug development process, which can lead to cost savings for patients and spur the development of new treatments.

On Sept. 14, 2017, the U.S. Food and Drug Administration approved Mvasi (bevacizumab-awwb, Amgen Inc.) as a biosimilar to Avastin (bevacizumab, Genentech Inc.). Mvasi is the first biosimilar approved in the U.S. for the treatment of cancer.

Introduction:

The global biosimilars market is expected to reach USD 10.90 Billion by 2021 from USD 3.39 Billion in 2016, at a CAGR of 26.3% during the forecast period. The major factors driving the growth of this market are the increasing demand for biosimilar drugs due to their cost-effectiveness, growing pressure to curtail healthcare expenditure, rising geriatric population, strategic collaborations resulting in enhanced productivity and clinical trial activities for biosimilars, and increasing government support and initiatives to develop and promote biosimilars.

On the basis of product,

The biosimilars market is segmented into recombinant non-glycosylated proteins, recombinant glycosylated proteins, and recombinant peptides. In 2018, the recombinant non-glycosylated proteins segment is expected to account for the largest share of the market. New product launches, cost-effectiveness, growing incidence of diabetes, and presence of many biosimilar versions of insulin in the pipeline are the factors driving the growth of this segment.

Based on manufacturing type,

The biosimilars market is segmented into in-house manufacturing and contract manufacturing organizations. In 2018, the contract manufacturing segment is expected to account for the largest share of the market

Based on application,

The biosimilars market is segmented into oncology, blood disorders, chronic and autoimmune diseases, growth hormone deficiency, infectious diseases, and other applications. The oncology segment is expected to grow at the highest CAGR during the forecast period. The rising incidence of cancer, high cost of biologics, pressure to reduce healthcare expenditure, and low cost of biosimilars are factors contributing to the growth of this segment.

Based on region,

The global biosimilars market is segmented into North America, Europe, Asia, and RoW. Asia is expected to grow at the highest CAGR during the forecast period. This can be attributed to factors such as the low per capita consumption, rapid growth in economies, the rise in technological innovation, trade links, and the rise in medical tourism.

The key players in the biosimilars market include Pfizer Inc. (U.S.), Sandoz International GmbH (Germany), Teva Pharmaceuticals Industries Ltd. (Israel), Amgen Inc. (U.S.), Biocon Ltd. (India), Dr. Reddy’s Laboratories (India), F. Hoffmann-La Roche Ltd. (Switzerland), Celltrion Inc. (South Korea), and Samsung Bioepis (South Korea).

American Market: The USA is the largest market for biologics globally. With the approval of the first biosimilar in the U.S in early 2015 and the expected patent expiration of 12 biologics by 2020, biosimilars are expected to competitively penetrate the biologic's market.

In 2010, patient care act was passed by Obama which gives licensure pathway for interchangeable products, which provided under the part of Biologics Price Competition and Innovation Act for the product demonstrating as biosimilar, manufacturers need to submit Biologics License Application (BLA). Target reference products for the USA market are Monoclonal Antibodies (MAbs), recombinant protein and some high-purity protein products, out of which recombinant therapeutic with the large market (sales) even with a small profitable amount.

Biosimilar market is expected to represent CAGR of 62.2 % as the chances of growth of biosimilar market from $1.7 billion in 2014 to $30 billion by 2020.

Biosimilars will account for 4% to 10% of the biologics market total by 2020, depending on the number of biosimilars launched in the U.S. The U.S. is the largest market for biologics and the biosimilars can achieve 10% of the global sales in 2020, only if the volume growth for biologics is achieved in the U.S. market.

The main players looking to penetrate the US biosimilar market are currently Amgen, Mylan, Pfizer, Sandoz and Hospira.

Global Biosimilar Market:

While the U.S. has approved only one biosimilar therapeutic; Japan, Australia and Europe have approved six, eight and 19 biosimilars respectively. Already, biosimilars have an exemplary safety track record in the E.U., Japan, and Canada where biosimilars are regularly competing against biologics for nearly seven years. The E.U. was the first geographic market to develop the process of authorization of biosimilars, setting an example for many other developing markets to follow suit. As of 2015, the E.U. has approved 19 biosimilars, out of 21 submissions, mostly for three reference biologics such as Somatropin, Epoetin alfa and Filgrastim.

Biosimilars generated revenues of $1.1 million in 2007 and gradually rose to $86.9 million in 2014. During this period, the market penetration of biosimilars in Europe and emerging markets was only about 8%. The top five biologics targeted most by biosimilar developers are Avastin, Enbrel, Herceptin, Humira and Rituxan, which together generate revenues of about $50 billion annually.

Biosimilar market in Europe:

Patent expiration and increased use of traditional generic drugs are leading to a shift of focus in the pharmaceutical industry toward investment in specialty drugs and high growth areas such as biosimilars in Europe. patent expiry of key product classes and a growing emphasis on cost-effectiveness are making governments switch to affordable alternatives.

The EMA approved four additional biosimilars in 2016, including three biosimilars in two new product classes: a biosimilar of Amgen’s Enbrel (etanercept) and two biosimilars of Sanofi’s Clexane (enoxaparin sodium). Etanercept is a fusion protein used to treat a variety of autoimmune disorders and enoxaparin sodium is a low-molecular-weight heparin indicated for preventing blood clots. These additional approvals bring the total of currently authorized biosimilars in Europe to 22 and the product classes to eight

It was estimated that in 2015, Europe accounted for the largest market share of the global biosimilars market, followed by Asia Pacific.here is thus a tremendous opportunity for biosimilar manufacturers. However, the development of biosimilar drugs is riddled with complexities, from R&D to manufacturing to marketing, and is one of the most expensive propositions in the pharmaceutical industry.

About 30 companies are actively developing biosimilar medicines and are researching on the biosimilar versions of 16 distinct molecules that will lead to greater competition by 2020, with 8 major biologic medicines expected to lose exclusivity by 2020.

The next five years are going to be an interesting period in the biosimilars market as a number of biologic drugs are going to lose their exclusivity.

The biosimilars market in Asia Pacific: Asia-Pacific is the fastest growing market for biosimilars because of low manufacturing expenses, availability of skilled and cheap labor, lenient regulations laid by governments. In fact, governments are encouraging the use of biosimilars. For example, the government of India provides various necessary and regulatory procedures for the usage of biosimilars products.

Asia-Pacific Biosimilars Market was worth $0.78 billion in 2016 and estimated to be growing at a CAGR of 39%, to reach $4.05 billion by 2021.

Based on geography the Asia-Pacific market is segmented into various regions namely Japan, China, India and Australia.

India and China are estimated to grow the fastest. Other countries such as South Korea are also expected to record high growth over the next five years. India is one of the largest hubs for the biosimilar industry and observes a presence of over 30 leading firms that operate in the development of biosimilars, some of which include Dr. Reddy’s Laboratories, Wockhardt, Lupin, Cipla, Avesthagen, Biocon, and Zydus Cadilla.

Some of the major players in the biosimilars market in Asia Pacific:

Biosimilar market in the Middle East: The Middle East and Africa Biosimilars Market was worth $0.37 billion in 2016 and estimated to be growing at a CAGR of 32%, to reach $1.63 billion by 2021.

Biosimilars are rising as a standout amongst the most vital area in the medicinal services industry. With expanding social insurance costs, biosimilars are being looked upon as a moderate treatment alternative. Developing economies are watching far-reaching development in biosimilars industry from requesting clinical necessities of therapeutics. Ascend in GDP and human services consumptions, and the interest for practical therapeutics arrangement has brought about the development of this market.

Few Global Universities for Biosimilars:

University of California, USA
North Carolina State University, USA
University of London, UK
Biotechnology Information Institute, USA
University of Toronto, Canada
Biotechnology Information Institute, USA
USC Keck School of Medicine, USA
University of La Sabana, Colombia
University of Pannonia, USA
USC Keck School of Medicine, USA
Touro College of Pharmacy, USA

Global Societies and Associations for Biosimilars in the USA:

Global Societies and Associations in Asia:

National Center for Nanoscience and Technology
Indian Society for Nanomedicine
Nano Technology Research Association
Indian Society of Nanomedicine

Global Societies and Associations in Europe:

Medicines for Europe
British Biosimilars Association (BBA)
Europian Medicines Agency
European Association of Hospital Pharmacists
International generic and biosimilar medicines association (IGBA)
Nanotechnology Industries Association
Royal Microscopical Society
Royal Society - Nanotechnology and Nanoscience
British Society for Nanomedicine

Conclusion: Like most other markets, a competitive biologics market can offer benefits to consumers by lowering prices and enhancing quality. In addition, biosimilars have an unblemished safety track record in the E.U., where biosimilars have been competing against biologics since 2006. Biosimilars have also proved to have a notable impact on drug prices. In the E.U., where biosimilars are already competing with biologics, biosimilars are sold at a 30% discount compared to branded biologic drugs.

Though biosimilars industry faces many challenges like Patent and Legal Issues, Production Bottlenecks, Pricing Issue, Regulatory issues and lack of awareness.

In spite of the approval of 21 biosimilars in Europe, only 18% of the physicians are aware of these similar versions of biologics. However bisimilar industry seems to have a bright future as an alternative to patent biologics.

References:

https://www.marketsandmarkets.com/PressReleases/global-biosimilars-product-market-worth-19.4-billion-by-2014.asp

https://www.omicsonline.org/open-access/biosimilar-drugs-market-future-trends-in-unitedstates-2153-2435-1000543.pdf

https://www.prnewswire.com/news-releases/global--usa-biosimilar-market-analysis-report-2015-2021-300134719.html

https://www.biosimilardevelopment.com/doc/biosimilars-market-europe-forecast-to-0001

https://www.biologicsblog.com/biosimilars-europe-2016-year-review-whats-ahead

http://www.marketdataforecast.com/market-reports/asia-pacific-biosimilars-market-1145/

https://www.medgadget.com/2017/11/asia-pacific-biosimilars-market-to-hold-a-share-worth-over-usd-4-05-billion-in-2021.html

https://en.wikipedia.org/wiki/Biosimilar

https://www.investopedia.com/news/top-4-challenges-biosimilar-growth-amgn-nvs/

Highlights
Supporting Journals

Biosimilars- Hatch-Waxman Act & BPCI Act
Challenges in Developing Biosimilars
Current Developments in the Field of Biosimilars
Emerging Trends in Biosimilars
Cost Analysis of Biosimilars
Clinical Studies on Biosimilars
Innovative Approach for Biosimilars
Consequences of Brexit on Biosimilars
Biosimilars Market- Challenges & Prospects
Globalization of Biosimilars
Intellectual Property Rights
US-FDA Approved Biosimilars
Biosimilars Approved in Europe
Biosimilars in Cancer Therapy

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11 Organizing Committee Members

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26 Renowned Speakers

Sarfaraz K. Niazi

Executive Chairman, Karyo Biologics, University of Illinois
USA

Ronald P. Dudek

Director of Technology Development and Marketing, Lentigen Technology, Inc.
USA

Valderilio Azevedo

International advisory board of Alliance, Safe Biologic medicines General coordinator, Latin American Forum on Biosimilars Adjunct professor of Rheumatology, Federal University of Parana, Brazil, Member of the Executive Commite, Americas Health Foundation
Brazil

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Media Partner

Dear Julie, Many thanks to you as you offered me this opportunity to come and participate at this valuable event in Chicago. I think you are great professional and made huge efforts for the event in terms of organization, engaging speakers, etc. And also you have sense for people, act as empathic person what is very important for me. I was very happy and honored to be invited as a speaker at World Biosimilars Conference in terms to present company Ewopharma AG as business partner of different pharma companies in Central and Eastern Europe, especially company Biogen with its portfolio of biosimilars and share my commercial experience in launching biosimilars! I found the conference interested in terms you selected very qualitative speakers from different areas: innovation and science, manufacturing and commercialization. From my perspective, the most interesting topics were: Sarfaraz K Niazi: “Biosimilars: Why are they so widely misunderstood?” Ronald P Dudek: “The adapter CAR Platform: From antibody to CAR T cell therapeutic” Jose Carlos Ferreyra Lopez: “Market access barriers and market value in Mexican public sector for biosimilars” Milind Antani: “Similar biologics in India- Impact of regulations on business” Joel I Osorio: “RegenerAge System “ (So I will be very happy if you could share these mentioned presentations with me!). I can see more potential for further improvement to put 100% focus on Biosimilar topics and to attract more specialists/professionals to gather. It will be excellent if you could attract more speakers from Europe to share their experience. So please consider this option how to attract them in the future (if I got some nice ideas will share with you!).
Sandra Simic

Great experience!! Thanks a lot for the opportunity to speak.
Jose Carlos Ferreyra Lopez

World Biosimilars Conference

Biosimilar 2018

Theme: New innovations in Biosimilars

11 Organizing Committee Members

26 Renowned Speakers

Sarfaraz K. Niazi

Ronald P. Dudek

JosÃ© Carlos Ferreyra LÃ³pez

Valderilio Azevedo

Milind Antani

Roberto Valenti

Joel I. Osorio

James (Jim) Stout

James M. Sulzberger

William Rushton

Sandra Å imiÄ‡

Rafiq Islam

Yazan shaban

Stephen Murby

Klara Valko

Aaron Barzey

Cecil Nick

Hareesh Parandhaman

Nicola Travierso

James Harris III

Ines Fradi

Divya Chadha Manek

Aparna Kasinath

Shimuye Kalayu Yirga

Sandesh Warudkar

Sumant Chaubey

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