Business of Biosimialrs Day 2: Celltrion, G. Steven Burrill and more

Today's guest post features highlights from the first day of the Business of Biosimilars and Generic Drugs Summit and is authored by Amy M. Belton, PhD, Research Associate, Johns Hopkins University School of Medicine.  The recap for Day 1 of Business of Biosimilars and Generic Drugs is here.

The 13^th Annual Business of Biosimilars and Generic Drugs meeting officially opened today with a presentation from the session chair Carrie Burke, Director of Alliance Development, Shire. Carrie gave an overview of the healthcare market with a description of the cost pressures associated with biosimilar development. She was also able to assure the audience that given the current US political climate, it is unlikely that the Biologics Price Competition and Innovation Act (BPCIA) would be affected. She also gave an overview of the BPCIA She also gave a brief overview of the recent draft guidances released by the FDA and offered clarifications for much of the language in the draft guidances released by the FDA earlier this year.

Mr. G. Steven Burrill, CEO Burrill and Company gave an overview of how technology is influencing the future of modern medicine, suggesting that within the next 5-10 years digital healthcare will revolutionize medicine. He discussed many of the modern ideas of digital healthcare and placing a patients healthcare in the palm of their hands. An example, is the AliveCor ECG app for iPhone which is a wireless, clinical quality cardiac event recorder that allows users to monitor heart function in real time. This information can be stored and uploaded for later use. He also described a new business model “co-opetition” or “cooperative competition” in which companies that were traditionally rivals partner in order to reach a competitive advantage. This can be seen in many of the partnerships forming between multinational drug manufacturers and generic companies. He also discussed the need to accept that emerging markets are here to stay but that big Pharma is not giving up without a fight. Mr. Burrills presentation offered a broad forecast into the future of the biotherapeutics space while keeping in mind that the power to determine the success of a biosimilar lies in the payer and not the regulatory hurdles required for approvals.

A portion of the business focus of Xencor is the development of superior biotherapeutics, which they refer to as biosuperiors. Xencors proprietary Xtend™ Technology, which is used to develop biosuperiors of old antibodies, was described by John Kuch, VP Finance, Xencor. The biosuperiors are apart of Xencors proprietary candidates pipeline having a modified Fc region by changing two amino acids. Various biosuperiors have been designed to have an increased in vivo half-life that can result in new dosage routes, increased patient convenience and reduced cost. These changes result in a biosimilar molecule whose dose and frequency can be modified to make the biosimilar more attractive to payers. One key aspect of Xencors technology is that biosimilar manufacturers can effectively integrate a key differentiator between a competitors biosimilar and their own. The biosimilar technologies developed using Xencors, Xtend™ Technology, could also result in a biosimilar developer receiving approval as a new therapy with increased efficacy, lower cost and more convenience for the patient. The Xtend™ Technology was an example of the types of advantages that biosimilar manufacturers have to incorporate into their biosimilar technologies. Simply developing, testing, and manufacturing a biosimilar is not enough to be a winner in this market. Manufacturers will also have to incorporate the better, faster, cheaper model to biosimilar development. As evidenced by the history of the generics market, being just as good as the innovator is not enough to be competitive. Biosimilar manufacturers will have to incorporate key differentiators into the development of biosimilar therapies in order to truly be competitive.

Several of Xencors proprietary biosuperiors for autoimmune and cancer targets are currently available for licensing.  Visit Xencors webpage.

One of the most anticipated talks for this meeting was given by Dr, ShinJae Chang, VP of R&D, Celltrion in reference to Celltrions biosimilar Remsima which was recently approved by the Korean FDA and is now under review by the EMA. During his presentation Dr. Chang gave a detailed profile description of Celltrion and its capacities in developing biotherapeutics. Celltrion has been in business since 2002 and is currently the largest company on the KOSDAQ (equivalent to US NASDAQ). Remsima is the world’s first biosimilar monoclonal antibody developed using internationally recognized regulatory standards. Remsima is a biosimilar of Janssen Biotech’s blockbuster biologic Remicade which reportedly had global sales of nearly $9 billion dollars in 2011 alone. Given the decreased manufacturing costs Celltrion offered a detailed overview of the comparability data first presented at the European League Against /Rheumatism in Berlin, Germany back in June 2012. Since then, Celltrion has not only received KFDA approval for Remsima but has also submitted an application to the EMA for approval in Europe which they expect to hear the results later this year. Dr. Chang shared much of the impressive quality comparability data for the Remsima biosimilar when compared to the innovator Remicade and the clinical trial strategy. We were also shown Celltrions global marketing strategy for biosimilars which includes partnerships with companies such as Hospira. As a result of its success and the potential global demand for Remsima, Celltrion has plans to increase its workforce by almost 13% by the end of 2012. In addition, they are working on their product pipeline which includes eight biosimilar monoclonal antibody therapies and five novel drug candidates in its R&D division. The future for Celltrion appears bright as they were the first to reach the finish line in developing biosimilars.

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