News Feature | December 23, 2014

FDA Accepts Apotex's Application For Biosimilar Cancer Drug

By Suzanne Hodsden

Apotex announced the FDA had accepted their application for pegfilgrastim, a biosimilar product based on Amgen’s blockbuster Neulasta, Pharmaceutical Processing (PharmPro) reports.

The FDA has, thus far, accepted only three biosimilar applications. First was Sandoz, a Novartis subsidiary, which filed an application for a biosimilar version of Amgen’s Neupogen.  Second, was Celltrion’s biosimilar product, Remsima, based on Johnson & Johnson’s Remicade.

Neulasta is a long-lasting formulation of Neupogen, a treatment used in conjunction with cancer therapies which boosts white blood cells to help the patient fight off infection and fever. Pharmpro cited IMS Health which put the financial earnings of Neulasta at $3.6B in 2013.

Amgen’s patent for Neulasta is set to expire in December of 2015.

Jeremy Desai, CEO of Apotex, reported that the new product was the first biosimilar version of Neulasta to submit an application to the FDA. Furthermore, he remarked on the benefits of biosimilar research.

Desai said, “The benefits for patients, payers, and providers from biosimilars will be significant. We are dedicated to playing a leading role in the effort to increase the American public’s access to more affordable versions of life-saving therapies and generate substantial savings for the U.S. healthcare system.”

Ralph Neas, president of the Generics Pharmaceutical Association (GPhA), recently remarked that if only 11 of the most likely biosimilar candidates enter the market, patients stand to save more than $250 billion over the following ten years.

According to the Regulatory Affairs Professionals Society (RAPS), the Biosimilar Price Competition and Innovation Act (BPCIA) was worked in as a provision of the Patient Protection and Affordable Care Act (PPACA) in 2010, and thus created a pathway for biosimilars to gain the approval of the FDA.

While the 351(k) pathway is very similar in premise to the 505(j) pathway governing pharmaceutical generics, the subject is still hotly debated among drug makers and legislators alike.

At issue here is the subject of interchangeability. While it is fairly straightforward to formulate chemical-based generics which mimic the effects of a branded product, biologic products are far more complex and almost impossible to duplicate.

Ostensibly, the biosimilar drug maker would have to provide clinical evidence that a patient could switch back and forth between the potential product and its referent biologic will little or no change to the treatment’s efficacy. The FDA released a draft guidance of what this process might look like in May of 2014.

According to the Regulatory Affairs Professionals Society (RAPS), the FDA expects to publish a finalized version of this guidance relatively soon.

Still, many feel the FDA has been dragging its feet on establishing a protocol for biosimilar evaluation when many other countries around the globe already have these treatments on the market. The EMA, by comparison, released a finalized guideline on biosimilars in October.