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Biosimilars Council Wants Elimination of 6-Month Exclusivity for Biologics


The Biosimilars Council, a division of the Association for Accessible Medicines (previously the Generic Pharmaceutical Association), filed an amicus brief with the Supreme Court arguing that the biologic manufacturers should not get an additional 6 months of market exclusivity beyond the current 12 years. Sandoz received FDA approval of filgrastim-sndz (Zarxio), a biosimilar of Amgen’s reference filgrastim Neupogen, in March 2015.

The brief is in advance of the Court’s April 26th hearing of oral arguments for the dispute between Sandoz and Amgen over whether a Federal Circuit Court ruled properly in granting an additional 6 months of exclusivity to biologic sponsors based on a provision of the Biologics Price Competition and Innovation Act of 2009 (BPCIA). The Biosimilars Council noted that Congress gave sponsors a period of exclusivity that is 12 years and 12 years only, extendable only based on pediatric research: “No one referred to the period as 12 1/2 years, as respondents would have it.”

Under the BPCIA, biosimilar applicants must provide notice to the reference product sponsor no later than 180 days before the date of the first commercial marketing of the biological product. Sandoz argues that the Federal Circuit “turned this mere notice provision into a grant of 180 days of additional exclusivity for all biological products beyond the exclusivity period Congress expressly provided—delaying the launch of all future biosimilars by six months.”

The Biosimilars Council argues that the notice allows patent litigation to precede a biosimilar’s launch, not to “make the parties wait for a ‘fully-crystallized controversy’ before litigation begins.”

The additional 6 months of exclusivity would translate into a huge loss of potential cost savings for patients and payers. The brief states, “For an individual Medicare Part B beneficiary responsible for thousands of dollars per year in cost-sharing payments for a biologic drug that costs $50,000 or even $200,000 per year, or for a patient with private insurance and similar cost-sharing obligations, the six-month savings could mean the difference between selecting and forgoing much-needed therapies for serious illnesses.” Sandoz believes that the additional exclusivity period will shift billions of dollars from patients, federal programs, and insurance premiums over to biologic sponsors.

For manufacturers of these biosimilars, too, the extra 6 months of market exclusivity is a very significant issue, because developing and manufacturing biosimilars is particularly costly and time consuming (an average cost of $100 million and $200 million, over a period of 8 to 10 years), on top of the $250 million to $1 billion investment required for companies to build, equip, and qualify manufacturing facilities. “A further delay before companies can begin to recover their substantial investment is likely to shrink the universe of potential candidates still further,” the brief adds.

However, the Biosimilars Council said the Federal Circuit Court was correct to hold that when a biosimilar applicant decides not to provide its confidential information to a biologic sponsor, the sponsor’s sole remedy is the one set out in the statute, which is a patent infringement action. Just last week, Genentech filed a lawsuit against Amgen for withholding this information. The United States has the world’s longest period of exclusivity for biologics. Europe has 10 years; Canada, 8; and other countries (Australia, New Zealand, Japan, and South Korea) have 5 or 6 years of market exclusivity.

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