Biosimilar drugmakers to share information with Congress in quest to speed product approvals

A Congressional panel examining the applications of high-profile biotech companies to market their products to consumers will meet on Tuesday to hear representatives from the Food and Drug Administration, Cambridge, Mass.-based Moderna Therapeutics, the…

Biosimilar drugmakers to share information with Congress in quest to speed product approvals

A Congressional panel examining the applications of high-profile biotech companies to market their products to consumers will meet on Tuesday to hear representatives from the Food and Drug Administration, Cambridge, Mass.-based Moderna Therapeutics, the San Francisco-based pharma company ayuImmune and Pfizer’s BeXotax.

Representatives from Pfizer and Moderna have received government approval to begin marketing treatments that are designed to help treat a range of rare genetic disorders, including lysosomal storage disorders and genetic diseases that affect body metabolism. Pfizer’s eptinezumab, a long-acting biosimilar to the blood thinner warfarin, received FDA approval in September 2017. MuSoma was approved by the FDA in April 2018 for use with long-acting protein infusion to treat Gaucher disease type 1, a genetic disease that leads to enlargement of the liver and spleen and can lead to life-threatening symptoms. MuSoma costs around $300,000 per year. AyuImmune’s multiplexed interferon lambda was approved by the FDA in February. It is designed to help patients suffering from flu-like symptoms. Pfizer and Moderna will both market their treatments to both adults and children.

The C.D.C.’s Vaccine, Injectable Anti-Infective and Inflammatory Drugs Subcommittee has already held a public hearing last month where it heard the non-exclusive commercial licenses (NULs) for the three companies’ products and discussed the guidelines for approving drugs with high-profile names and limited history of clinical trials. Pfizer, by comparison, has a relatively lengthy history as a pharmaceutical company — and the previous C.D.C. committee meeting highlighted that history, as Pfizer executives tried to defend against criticisms that its approach to filing a NUL with the FDA was cumbersome and tedious. (Pfizer used the “industry standard approach” to a NUL, or one of multiple forms of a pharmaceutical drug’s marketing application, in its submissions to the FDA.) “We submit a list of evidence in response to any questions posed by the FDA and that information is summarized in the NUL,” Pfizer’s executive vice president and general counsel for health care business Glen Tullman told the committee at the hearing, according to a C.D.C. summary. “This method of submission, is well-accepted industry practice and provides an efficient and cost-effective process.”

Moderna has told the C.D.C. committee that it “contemplated including ‘broadly beneficial data’ beyond the pre-approval efficacy data, including data on safety, immunogenicity, pharmacokinetics, and response rates, from the [biosimilar] study as supplemental to its current product package insert,” according to the C.D.C. summary of its hearing. The C.D.C. will meet again on Tuesday to review the pre-market applications of all three companies’ products.

The committee’s chairman, Rep. Marsha Blackburn, a Tennessee Republican, has been critical of the lengthy traditional process of bringing new drugs to market, writing last year in a Wall Street Journal op-ed that “it was former CEO Jack Abramoff’s favor-peddling schemes that kick-started the American deregulation era. The bribery plot he orchestrated gave him control of Congressmen on Capitol Hill, enabling him to pass deregulation and legislation that was later under inquiry by Congress’ investigative arm.”

Blackburn has expressed interest in pursuing a solution to reduce or delay lengthy processes to bring pharmaceuticals to market, and in Sept. 2018, the C.D.C. voted to publish guidelines to shorten the time it takes to bring new drugs to market. Wednesday’s meeting of the committee will provide an early read on whether the guidelines have had an impact on fast-tracking of new drugs’ applications.

Read the full story at The Hill.

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