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Biosimilar Regulatory Roundup: March 2019


March 2019 kicked off with a surprise, when FDA Commissioner Scott Gottlieb, MD, announced he was leaving the administration. In addition, the FDA released updated draft guidance on the naming of biologics, biosimilars, and interchangeable biosimilars; approved a Pfizer biosimilar; and more.

The man many in the biosimilar world credit with being proactive about government efforts to educate and develop the industry in the United States gave his 1-month notice early in March 2019, and that was just the start of a flurry of regulatory news this past month.

FDA Commissioner Scott Gottlieb, MD, is leaving his post, with his last day set to be April 5, just 2 days after he testifies about the FDA’s budget request to Congress. He will be replaced by Ned Sharpless, MD, who has a track record with the biotechnology industry and oncology and is said to have a friendly relationship with Gottlieb.

Still, all of the major biosimilar organizations expressed surprise and regret about Gottlieb’s decision; most observers credit him with a sea change at the FDA.

However, days later biosimilar developers were even less pleased about the FDA’s updated draft guidance on the naming of biologics, biosimilars, and interchangeable biosimilars. According to industry, the FDA’s decision to require 4-letter, nonmeaningful suffixes for biosimilars, interchangeable biosimilars, and new biologics—but not already approved biologics—could seriously hinder biosimilar uptake.

In addition, the International Generic and Biosimilar Medicines Association, a global umbrella group, called the US policy a “notable outlier” that diverges from global consensus on biosimilar naming. The draft guidance also drew the attention of an adjunct professor and founder of biosimilar companies, who filed a citizen petition with the FDA seeking that the guidance be withdrawn.

Sarfaraz K. Niazi, PhD, adjunct professor of biopharmaceutical sciences at the University of Illinois and the University of Houston, is asking that the agency modify its position to state that no suffixes are required for any biologic products and instead state that brand names can be used along with National Drug Codes (NDCs).

In other FDA news, it approved Pfizer’s trastuzumab-qyyp (Trazimera), a biosimilar referencing Herceptin. Trazimera earned EU authorization in July 2018.

The FDA also issued a Form 483 to Biocon after a February 2019 inspection of its Bangalore, India, facility. One issue documented by the FDA says that procedures designed to prevent microbiological contamination are not established or followed and points out a lack of appropriate procedures to prevent contamination on the drug product fill line. The second issue states that written records of investigations into unexplained discrepancies sometimes lacked adequate conclusions or follow-up.

Biocon acknowledged the Form 483, saying that it was related to a preapproval inspection of a new injectable manufacturing line. A representative from Biocon said that the company has already addressed the observations and made a response to the FDA.

In European regulatory news, the European Commission approved Roche’s innovator rituximab, sold in Europe as MabThera, for the treatment of pemphigus vulgaris (PV), a rare autoimmune disorder. The approval marks the first biologic approval for PV in the European Union and the first major new therapeutic option in 60 years.

In Japan, Lupin and YL Biologics received approval to manufacture and sell YLB113, a biosimilar etanercept product. The product will be Lupin’s first biosimilar to come to the Japanese market.

Back in the US capitol, 2 senators launched a bipartisan effort to address the issue of patent thickets. Senator Susan Collins, R-Maine, and Senator Tim Kaine, D-Virginia, introduced the Biologic Patent Transparency Act, which would require companies to publicly disclose the patents that protect their originator biologics, thus making it easier for competitors to evaluate and plan for the development of biosimilars.

The House Committee on Energy and Commerce held a Health Subcommittee legislative hearing on lowering the cost of prescription drugs. The 7 bills that were the subject of the hearing include several items of legislation that have long waited for congressional action as well as new proposals to address the need for increased competition. They include the Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act, which would allow a biosimilar or generic developer to bring a civil action against an innovator drug company if the latter refuses to make available enough samples of a product for testing.

It also includes the Fair Access for Safe and Timely Generics (FAST Generics) Act. This proposed legislation would amend the Federal Food, Drug, and Cosmetics Act to prohibit license holders of FDA-approved drugs or biologics from restricting availability of their products for testing by competitors who seek to develop generics or biosimilars. It would also stipulate that Risk Evaluation and Mitigation Strategies cannot restrict the supply of samples to generic or biosimilar developers.

Lastly, the White House released its budget blueprint for fiscal year 2020—the one that Gottlieb will testify about before he leaves Washington, DC, for his Connecticut home. The HHS section of the budget includes a number of proposals to advance the Biosimilar Action Plan and promote competition in the coming year.

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