Biosimilars market rises

A new report suggests that specialty pharmaceuticals are growing in proportion of total pharmaceutical spend in the United States as well as in cost to the patient and healthcare system at an unsustainable rate.

Biosimilars also known as follow-on biologics are biologic medical products whose active drug substance is made by a living organism or derived from a living organism by means of recombinant DNA or controlled gene expression methods. Biosimilars (or follow-on biologics) are terms used to describe officially approved subsequent versions of innovator biopharmaceutical products made by a different sponsor following patent and exclusivity expiry on the innovator product.

The Biologics Price Competition and Innovation Act (BPCIA) of 2009 was enacted as part of the Patient Protection and Affordable Care Act on March 23, 2010, to alleviate some of those pressures. It amended the Public Health Services Act to include an abbreviated pathway in section 351(k) for biological products shown to be biosimilar to or interchangeable with an FDA licensed reference product. The BPCIA opened the door for biosimilar versions of already approved biologics where “generic” competition did not exist prior.

The FDA continues to clarify biosimilar guidelines. The most recent draft guidance providing additional details was published on May 2014. In an article for Pharm Pro, Sarfaraz K. Niazi examines current FDA regulations and explores the state of the market.

Then article can be accessed here.



Posted by Tim Sandle