BioProcess Blog |

Welcome to the BioProcess Blog, our new medium for sharing information and ideas with our clients, colleagues, and others interested in the development of biopharmaceutical products. Our objective is to expand the information already available on our website and to provide a forum for discussing current trends, challenges, and opportunities in the biopharmaceutical industry.

In the past couple of years we have seen much interest in developing biosimilars or follow-on biologics. Many companies are now developing biosimilars in hopes of capturing market share from some of biotech’s biggest blockbuster products.

Guidelines and regulations already exist in Europe for the approval and marketing of these products and it is increasingly likely that some form of biosimilar legislation will be approved soon in the US. BPTC has been following the biosimilar debate for some time and recently participated in the Second Annual Bernstein Biosimilars Conference in New York, which focused on important trends and issues in this emerging segment of the biologics industry. In his presentation entitled “If You Build It, Will They Come? The Promise and Perils of Investing in Biomanufacturing Capacity,” Tom Ransohoff, Vice President and Senior Consultant at BPTC, provided an overview of current biomanufacturing capacity along with an analysis of the challenges facing companies developing biosimilars. The complexities of manufacturing biologics can make the development and manufacture of a biosimilar which is comparable to the original innovator product daunting for those with no experience in biopharmaceutical manufacturing.

The conference also featured presentations from leading biosimilars companies and others with different perspectives on the biosimilars field. Ronny Gal, Specialty Pharma Analyst for Bernstein, tied it all together with an overview of the challenges and opportunities in the follow-on biologics areas. Dr. Gal emphasized that the pending biosimilar legislation in the US is far more favorable to innovator companies than to biosimilars companies, putting significant roadblocks in the path of those who would like to use a generic-style approval process for biologics. As a consequence, he expects that many companies developing follow-on biologics, whether they be “bio-better” or “biosimilar” products, will use the traditional innovative development pathway rather than any biosimilar approval pathway for the foreseeable future. This is consistent with Teva Pharmaceutical’s February 2 announcement that FDA has accepted their BLA for XM002, or Neutroval, a biosimilar version of Amgen’s Neupogen. The product has been approved in several European countries, where it is sold under the name TevaGrastim, using their existing biosimilars regulatory pathway. Not wanting to wait for such a pathway in the US, Teva filed its BLA and said that its application treats XM02 as a new medicine, not a biosimilar.

We too expect many other companies developing biosimilars to go the BLA route in the US even after any biosimilar legislation is passed since the current proposals for regulating biosimilars call for extensive Phase 3 clinical trials, provide a potentially restrictive data exclusivity period, and do not grant substitutability of the biosimilar for the innovator product. This last item means that each “biosimilar” will have to be prescribed by the patient’s physician and pharmacies will not be allowed to freely substitute a biosimilar product for an innovator product as they can for small molecule generics. As a result, each biosimilar product will require extensive marketing to compete against the previously approved innovator and price discounts, if any, will be smaller compared to traditional generics. We believe that many companies faced with the significant R&D expense required to develop biosimilars and the extensive clinical trials required for their approval will opt to seek approval of their products as new medicines rather than biosimilars. Of course, this approach is not necessarily new when one considers the number of insulin, growth hormone, and Factor VIII products, for example, already on the market.