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Momenta's Biosimilars Strategy

Applying Innovative Science to the Development of Biosimilars and Potentially Interchangeable Biologics

Our strategic approach to biosimilars is built around a set of core tenets that we believe will position the company for long term success.

First, we believe it is essential to build a portfolio of programs. This will allow us to capture the scale, technology, and regulatory synergies that are possible in biologic products. We currently have a robust portfolio of biosimilar candidates at various stages of development.

Second, we seek to build a competitive advantage through our scientific approach to the development of biosimilar and potentially interchangeable biologic products. Over the years we have invested in a technology platform designed to engineer biosimilar products that are as close to the brand product as possible, with a goal of developing molecules that are indistinguishable from the brand and have the potential to achieve the designation of interchangeability from the Food and Drug Administration (FDA).

To accomplish this, our team has built a robust suite of capabilities including: 

  • A physicochemical analytic toolset, developed from our proven work in complex generics which has been adapted to enable full characterization of complex biologics such as monoclonal antibodies (mAbs) and fusion proteins. 

  • A process development and manufacturing effort guided by advanced technologies from cell line selection to full scale manufacturing, that enables us to produce high fidelity copies of the brand products.

  • A biocharacterization platform, evolved from the suite of biology tools we deployed during the development of our complex generics and novel oncology candidate necuparanib, which enables us to potentially reduce any remaining residual uncertainty regarding the comparability of our biosimilars to the brands, such that the clinical trial requirements for approval may be reduced and potentially one day eliminated. 

  • State of the art knowledge and experience in regulatory interactions and policy development for complex products.

All of this work is targeted at achieving competitive advantage in the regulatory and commercial arena. We seek to capture added value by reducing required trials, gaining extrapolation across indications, and ultimately achieving an interchangeable designation from the FDA. An interchangeable biological product is biosimilar to an FDA-approved reference product and meets additional standards for interchangeability1. An interchangeable biological product is a biosimilar that meets additional standards allowing for it to be interchangeable with the reference brand product.

The FDA has been clear that achieving fingerprint-like similarity, which is a high bar, is a direct path to a more selective and targeted development approach. Our approach has been designed from the start to achieve this goal. We believe our approach to developing biosimilars has the potential to provide us with a higher probability of success in engineering our biosimilars to be more precisely identical (e.g., fingerprint-like) to the branded product. Specifically, we believe we have a competitive advantage in achieving the goal of interchangeability.

The third tenet of our biosimilars strategy is to ensure that our products are positioned to capture the global opportunity available. We seek to identify and collaborate with partners who can bring global commercial capabilities and help drive low cost manufacturing strategies for supply that can maximize the overall return for each product.

 

1 Source: U.S. Food and Drug Administration http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/Biosimilars/

Last Updated 1/4/2016