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Biosimilar Regulatory Roundup: July 2019


July 2019 was a busy month for biosimilars on the regulatory front; not only did the FDA approve new products, but numerous policy proposals with a potential impact on biosimilar regulation were put forward by law makers.

July 2019 was a busy month for biosimilars on the regulatory front; not only did the FDA approve new products, but numerous policy proposals with a potential impact on biosimilar regulation were put forward by law makers.

First, Pfizer received the FDA’s approval for its rituximab biosimilar, Ruxience, referencing Rituxan. Ruxience is the second rituximab biosimilar to receive approval, and the first to carry indications for granulomatosis with polyangiitis and microscopic polyangiitis. However, the biosimilar did not receive approval for all indications of its reference, and Pfizer indicated that this fact is linked to Genetech’s exclusivity for Rituxan in certain indications.

On the same day that Ruxience entered the ranks of FDA-approved products, Samsung Bioepis also received approval for its biosimilar adalimumab, Hadlima, referencing Humira. The biosimilar is already approved in the European Union, where it is sold as Imraldi. Hadlima will not reach US patients until June 30, 2023, however, under the terms of a patent settlement with AbbVie, Humira’s developer.

Imraldi also got a boost in the European context this month with an approval for storage in nonrefrigerated conditions for up to 28 days, which could be a boon for the drug maker as it seeks to differentiate its product from biosimilar rivals; extended storage could be a benefit for patients who are unable to keep their biologic medicines at the recommended temperature due to limited access to continuous refrigeration.

Samsung Bioepis also announced that the European Medicines Agency will review its bevacizumab biosimilar, SB8, referencing Avastin.

Not all biosimilar developers were receiving positive regulatory news this month, however; Biocon issued a statement noting that the FDA had issued a Form 483 for its insulin facility in Malaysia. According to a spokesperson for the company, the Form 483 is not expected to impact Biocon’s timeline for commercializing an insulin glargine biosimilar in the United States.

The FDA was not the only regulatory body taking an interest in biosimilars this month; the Federal Trade Commission (FTC) has been seeking additional information into Johnson & Johnson (J&J) and Janssen’s strategies related to brand-name infliximab, Remicade. This month, it was revealed in a filing with the Securities and Exchange Commission that the FTC had issued civil subpoenas to the drug makers as part of an antitrust investigation. Biosimilar developer Pfizer filed a lawsuit in 2017 that alleged that J&J’s contracting practices sought to block biosimilars, such as Pfizer’s Inflectra, from formularies.

This month also saw a flurry of activity related to policy proposals that would impact the regulation of pharmaceuticals, including biosimilars.

First, the Congressional Budget Office released its score of the Senate Committee on Health, Education, Labor, and Pensions’ S.1895, saying that that the provisions of the bill, taken together, would reduce the deficit by $7.6 billion by 2029. Provisions specifically aimed at reducing the price of drugs (by means including allowing biosimilar and generic developers to sue drug makers who do not make samples of their products available for testing) would be responsible for a substantial share of those savings: $4.6 billion over the coming decade.

While S.1895 has garnered bipartisan support, one provision has raised concerns among many stakeholders: Section 207 of the bill would make would make biologics, including biosimilars, exempt from meeting quality standards set by the United States Pharmacopeial Convention. Critics of the provision say that rolling back quality standards puts patients at needless risk, and they have called on Congress to reject the provision.

Another bill put forward this month, S.2103, takes aim at products set to transition to regulation as biologics and biosimilars in 2020. The bill, introduced by Senators Dick Durbin, D-Illinois; Kevin Cramer, R-North Dakota; and Tina Smith, D-Minnesota, would amend the Biologics Price Competition and Innovation Act (BPCIA) to require that the FDA continue to review New Drug Applications for insulins that would otherwise have received Complete Responses if their applications were still pending by March 20, 2020.

Yet questions remain about whether the BPCIA itself will persist. Earlier this month, a federal appeals court heard arguments in Texas v Azar; if the judge in the case finds that the Affordable Care Act is unconstitutional, the BPCIA would also be invalidated. Two conservative healthcare leaders told The Center for Biosimilars®, however, that the BPCIA would likely be reinstated by Congress, and that it would be unlikely that Congress would take the opportunity to make changes to the law, which provides the regulatory pathway for biosimilar approvals and sets out the legal standard for interchangeability.

Some stakeholders are renewing their calls, however, for the world’s regulators to rethink interchangeability. In a recent paper, Hans C. Ebers, PhD, of Biogen, and Hubb Schellekens, MD, PhD, of Utrecht University, argue that interchangeability is simply a product characteristic that allows a medicine to be exchanged for another while producing the same clinical effect, regardless of whether that exchange takes the form of switching or pharmacy-level substitution. Given the body of evidence supporting biosimilars, and to boost confidence in these drugs, they say, regulators should acknowledge that biosimilars are, in fact, interchangeable with their references.

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