Regulatory Focus™ > News Articles > GPhA’s Biosimilars Council: BPCIA Provides 12 Years Exclusivity, Not 12.5

GPhA’s Biosimilars Council: BPCIA Provides 12 Years Exclusivity, Not 12.5

Posted 07 January 2016 | By Zachary Brennan 

GPhA’s Biosimilars Council: BPCIA Provides 12 Years Exclusivity, Not 12.5

The Generic Pharmaceutical Association’s Biosimilars Council is taking issue with a recent court decision that could effectively delay the launch of biosimilars in the US by an additional six months, according to an amicus brief.


Under the Biologics Price Competition and Innovation Act (BPCIA) -- authorized as part of Obamacare -- biosimilars can be approved via an expedited pathway and then marketed after their reference biologics are exclusively marketed for 12 years.

The US Food and Drug Administration will only accept biosimilar filings (known as 351(k) filings) five years after the original biologic is licensed by the US Food and Drug Administration. And after the filing is accepted, biologics and biosimilars manufacturers are expected to exchange patent and manufacturing information to help companies formally work out any disputes under what’s now commonly known as the “patent dance.”

However, at issue is a provision in the BPCIA that directs biosimilar makers to provide a 180-day notice to biologics manufacturers prior to marketing the biosimilar, but only after a biosimilar is licensed by FDA.

Amgen v. Apotex

In August, Amgen announced Apotex had provided it with a copy of its biologics license application (BLA) for a biosimilar of the neutropenia treatment Neulasta (pegfilgrastin) and exchanged information on the biosimilar's manufacturing and Amgen patents that the biosimilar could infringe on.

Amgen sued Apotex because Apotex argued that by complying with the information exchanges it was allowed to opt out of providing the 180-day notice of marketing.

In early December a federal judge in Florida ruled against Apotex and found that the 180-day notice provision is actually mandatory, though Apotex appealed that decision.

The only other case to deal with such a scenario involves Sandoz's biosimilar of Amgen's Neupogen, which is the first US biosimilar approved under the BPCIA. That biosimilar’s launch, approved as Zarxio, was delayed for 180 days after FDA approval because of the notice provision, although those companies did not engage in the so-called patent dance as Apotex and Amgen did.

Biosimilars Council

Now, GPhA’s Biosimilars Council is siding with Apotex in its appeal with the US Court of Appeals for the Federal Circuit and arguing that Congress never meant for the 180-day notice to add six months of exclusivity to biologics.

“By its very definition and as Congress intended, the 12-year exclusivity period should operate to prevent a biosimilar’s launch for only that length of time, and no more. Yet Amgen’s reading of the statute would frustrate this objective by making the end of the exclusivity period an essentially meaningless event, and the end of the notice period the true relevant trigger for marketing – again, for each and every biosimilar,” the council argues. “Congress clearly did not intend this result. This Court’s extension of its (erroneous) decision in Amgen v. Sandoz would have the additional effect of disincentivizing use of the section 351(l) patent dispute resolution provisions altogether – another consequence Congress could not have intended.”

In addition, the council argues against the Florida court’s insistence that the 180-day notice helps “crystallize” patent disputes.

And though 180 days may not seem like a long time to delay the entry of a biosimilar in the long run, in the case of Neulasta (which brought in $3.6 billion in sales in 2014 and $4.4 billion in 2013) and other biosimilars slated to hit the market in the coming years, those six months will amount to tens, if not hundreds, of billions of dollars.

Biosimilars Council Amicus Brief

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