Mylan partners to create FOBs

Generics manufacturers face higher barriers to entry to get into the FOB market and because they lack the in-house expertise are choosing to partner, with Mylan’s deal with Biocon being preceded by the collaboration between Teva and Lonza.

In Mylan’s case it was attracted to Biocon’s formulation experience, knowledge of regulatory requirements and biologics manufacturing capacity, which it intends to marry to its commercial footprint.

In doing so Robert Coury, Mylan’s CEO, believes they can “create a strong and effective long-term partnership​” that is capable of realising “tremendous growth potential​”.

The partnership covers all FOBs but is especially targeting monoclonal antibodies, which the companies believe are “emerging as the most dominant class in biologics​”.

Breakdown of the deal​

Under the terms of the collaboration the companies will share development, capital and certain other costs to bring products to market.

Mylan will have exclusive commercialisation rights for the US, Canada, Japan, Australia, New Zealand and countries in the European Union or Free Trade Association.

A profit sharing arrangement is in place for these regions, with both companies having commercialisation rights in all other areas. Further financial and product details are confidential.

Japan​ approves first FOB​

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Japan recently approved Sandoz’s recombinant human growth hormone somatropin, which becomes the first FOB to come onto the market in the country.

Guidelines for FOBs were published in Japan earlier this year, creating the framework for approval. The US now looks set to follow the EU and Japan and establish a regulatory pathway for FOBs.

Support for a shorter exclusivity period in the US increased recently when the Obama administration stated that seven years “strikes the appropriate balance between innovation and competition​”.

This falls well short of the 12-14 years that the biotech industry regards as essential to promote innovation and is closer to the period supported by the Generic Pharmaceutical Association (GPhA).