Mark Armstrong Quoted in Article About Biosimilar Law

Specialty Pharmacy News

Mark Armstrong, a Member of the Firm in the Health Care and Life Sciences practice, in the Houston office, was quoted in an article titled "Reading of Biosimilar Law Could Mean One Day or Years Until Competitors on Market."

According to the article, although the health reform law included a provision for an approval pathway for follow-on biologics, the legislation left the details of how that process would work to the FDA. With many questions still remaining on how the agency will interpret various aspects of the biosimilars provision — known as the Biologics Price Competition and Innovation Act of 2009 (BPCIA) — stakeholders have begun offering their opinions on how that portion of the law should be interpreted.

Payers, both commercial and government — and particularly Medicare — have been hoping to soon re­duce their tremendous spend on specialty drugs.

But payer interests are weighed against the interests of innovator manufacturers — "preserving innovation and receiving a return on their investment," said Armstrong.

"There is so much money at stake that everyone is trying to find some way to craft an argument to back their position," said Armstrong. "Pursuing research and being able to receive less expensive alternatives ... are both good objectives. ... The FDA has to find a way to balance this so there is a not a winner and a loser."

"I think the exclusivity period is arguably intended to allow generic competitors to be on the market in 12 years" after the reference product's licensing, Armstrong said.

According to Armstrong, "it's more likely than not that the FDA will be able to issue guidance that provides the detail people are looking for."