Will Some Biologics Get 30 Years of Exclusivity?

Regulatory NewsRegulatory News | 11 October 2019 |  By 

As the wrangling over the US-Mexico-Canada trade agreement continues, a provision to require Mexico and Canada to accept 10 years of biologic exclusivity stirred up controversy because it would be two more years than what Canada currently enjoys and add five more years for Mexico.

In the US, biologic exclusivity is set at 12 years. But in reality, a 30-year run for a biologic without competition is possible, following a court win for Amgen last August. And 15-plus years without competition has become the norm rather than the exception.

For instance, Pfizer recently announced that it would launch its Avastin biosimilar Zirabev (bevacizumab-bvzr), in the US on 31 December 2019. Avastin was first approved by FDA in 2004. Similarly, biosimilars for Remicade launched (with limited success) in late 2016 and Remicade was first approved by FDA in 1998.

For 30 years of exclusivity, however, the biologic in question is the blockbuster arthritis treatment Enbrel (etanercept), which is Amgen’s largest product, pulling in about $5 billion per year. Two Enbrel biosimilars have been approved in the US, but neither have launched and protecting Enbrel’s market control in the US has been of paramount importance to Amgen as Enbrel’s patents do not expire until 2028.

As far as Sandoz’s ability to challenge Enbrel and launch its competitor, a spokesperson told Focus: “Sandoz has appealed the District Court’s ruling with the United States Court of Appeals for the Federal Circuit on an expedited basis. Both parties have agreed and are committed to resolving the appeal, as quickly as possible. We anticipate a decision in the first half of 2020.”

Bernstein analyst Ronny Gal predicts the risk of a reversal of the initial court decision to be low, especially as, by his estimate, only about 20% of patent cases are reversed.

In the EU, however, both Sandoz and Samsung Enbrel biosimilars have launched and are gaining traction. Samsung said recently that its etanercept biosimilar is currently available in 25 countries in Europe and is the most prescribed etanercept across France, Germany, Italy, Spain and the UK. Biogen, which partners with Samsung, said in a recent earnings report that in the first half of 2019, the Enbrel biosimilar brought in $244 million.

In a report from July, Gal explained how Enbrel biosimilars in the EU control 47% of the total market, and in the UK, Biogen’s Enbrel biosimilar Benepali controls 69% market share, 50% in Scandinavia and 48% in Germany. A previous report from February showed 44% market share for Enbrel biosimilars and a price reduction of 49%.

So why is the US dragging its feet in adopting Enbrel biosimilars? Experts point to a mix of legal maneuvering and different ways to protect costly biologics from competition, which FDA and others have tried to combat.

Reed Beall and other researchers at the University of Calgary explained in a recently published article in Health Policy that, unlike with small molecule drugs, when it comes to biologics, “identical processes must be used (they are ‘products by process’) and are not easily replicated. Enough information to reproduce this process is not disclosed in the patent and these details may more accurately be regarded as a trade secret rather than a patented process. Unlike patents (and data exclusivities), trade secrets have no expiration. For these reasons, a lack of adequate market protections has not proven to be a challenge for biologics.”

Meanwhile, Democrats have introduced legislation to reduce the 12 years of exclusivity, which some predict could end up saving the US billions in the long run.

"In 2017, the Obama Administration Office of Management and Budget estimated that reducing the exclusivity from 12 to 7 years could save almost $7 billion over 10 years," the representatives said.


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