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Pfizer and Biocon Partner to Commercialize Biosimilar Insulin Products

David Simmons, President and General Manager of Pfizer’s Established Products Business Unit, and Kiran Mazumdar-Shaw, Chairman and Managing Director of Biocon, shake hands, ushering the start of a new and exciting partnership.

Do you ever wonder why there aren’t cheaper “generic” insulin products available? In five to ten years time, that will most likely be the case. Patents for Lantus (sanofi-aventis’ basal insulin glargine) expire in the US in 2015, while patents for other insulin products, such as Humalog (Eli Lilly’s fast-acting insulin lispro) and Novolog (Novo Nordisk’s fast-acting insulin aspart) expire within a similar timeframe. This leaves the door wide open for other companies to introduce “generic” insulin products after they receive the proper regulatory approval.

Unfortunately, the regulatory process for “generic” insulins is not clearly defined at this point. Insulin, unlike many other pharmaceutical products, is a “biologic.” What this means is that it cannot be synthesized chemically – instead it’s produced through biological processes (for example, Lantus uses a strain of bacteria which makes the insulin). With chemically synthesized drugs, it is relatively easy for companies to demonstrate that their generic drug candidates are “bioequivalents” – they have the exact same active substances, doses, routes of administration, availability, and identical safety and efficacy profiles to the original reference drugs. However, biologics can never be considered truly equivalent to the original reference compounds. This is because biologics can be quite sensitive to changes in manufacturing processes (for example, changes in cell lines used, changes in purification techniques, etc.). As a result, the FDA does not currently have clear guidelines for the approval of “generic” biologics, or, in scientific jargon, “biosimilars.” The FDA is well aware of this issue, and is holding a meeting on November 2nd and 3rd to discuss requirements for regulatory approval of biosimilars.

Earlier this month, Pfizer obtained worldwide rights from the Indian pharmaceutical company Biocon to commercialize products in Biocon’s biosimilar insulin portfolio, including their version of Lantus (currently branded as Basalog in non-US markets, and produced using yeast in contrast to bacteria), and their (early) versions of Novolog and Humalog. As we understand it, Pfizer and Biocon will seek approval for their biosimilar insulins in the US and Europe as soon as patents expire.

Since a regulatory pathway for biosimilars has not yet been established in the US, Biocon intends to proceed with a ‘hybrid’ approach that contains elements of a typical New Drug Application, (NDA) and an application for a generic drug. How long it will take is not yet known. --VW/ST