Regulatory

Scott Gottlieb, MD, commissioner of the FDA, who has been vocal about "shenanigans" used by innovator drug makers to forestall competition from biosimilars and generics, today announced the publication of a list of companies that have restricted access to samples of small-molecule drugs for testing through the use of Risk Evaluation and Mitigation Strategies programs or limited distribution of their products.

The American Association of Pharmaceutical Scientists (AAPS), a professional organization of 9000 scientists, has published a new white paper in The AAPS Journal that discusses the scientific and methodological considerations of the process of attribute and test method selection, criticality assessment, and assignment of analytical measures to the FDA’s 3 tiers of analytical similarity assessment for biosimilars.

The FDA has approved Pfizer’s biosimilar epoetin alfa, referencing Epogen. The biosimilar, epoetin alfa-epbx, which will be marketed as Retacrit, is the first biosimilar approved in 2018, and the tenth biosimilar to be approved in the United States.

HHS’ “American Patients First” blueprint for implementing Trump’s vision includes a proposal to address the potential misuse of Risk Evaluation and Mitigation Strategy programs to delay biosimilar competition.

The Center for Biosimilars® recaps the top 5 articles for the week of May 7, 2018.

Last week, the FDA announced that it will withdraw a direct final rule that proposed to amend general biologics regulations related to time of inspection requirements and to remove some duties of inspector requirements. In its statement withdrawing the rule, the FDA indicated that it had received significant adverse comments related to its proposal.

Lupin Pharmaceuticals has submitted a new drug application for its etanercept biosimilar, YLB113, in Japan, the company announced today.

Last week, the European Medicines Agency (EMA) released a report describing its contributions to science, medicines, and health for the year 2017.

This week, biosimilar developer Coherus announced that it has resubmitted a Biologics License Application (BLA) for CHS-1701, a pegfilgrastim biosimilar candidate referencing Neulasta.

The Center for Biosimilars® recaps the top 5 articles for the week of April 30, 2018.

Biosimilar developer Biocon has received the FDA’s Form 483 after a preapproval inspection of its Bangalore manufacturing facility resulted in 7 observations. The FDA issues Form 483 when an investigator conducting an inspection has observed conditions that may constitute violations of the Food, Drug, and Cosmetic Act or related acts.

Sandoz has announced that it has received a Complete Response Letter from the FDA for GP2013, its proposed rituximab biosimilar referencing Rituxan.

The United States Pharmacopeial Convention (USP) announced that it will not be moving forward with its proposed revisions to drug product monographs for biologic medicines.

Though the European Medicines Agency (EMA) has instituted guidelines for the development of biosimilars, approval of these drugs is possible even in cases in which the guidelines are not followed, and even in which primary endpoints in studies are not met.

April was a notable month for regulatory action on biosimilars in the United States, and for regulatory developments in Europe.

The Center for Biosimilars® recaps the top 5 articles for the week of April 23, 2018.

The United Kingdom’s Medicines and Healthcare Products Regulatory Agency (MHRA) has released its Corporate Plan for the coming 5 years. The plan seeks to address some of the uncertainty generated by ongoing negotiations between the United Kingdom and the European Union in light of the upcoming Brexit.

Pfizer announced this morning that the FDA has issued a Complete Response Letter for PF-05280014, a proposed trastuzumab biosimilar referencing Herceptin.

This week, Scott Gottlieb, MD, Commissioner of the FDA, addressed the US House Subcommittee on Agriculture and Rural Development, Food and Drug Administration, and Related Agencies, and made his case for increased funding for the FDA.

The Center for Biosimilars® recaps the top 5 biosimilars articles for the week of April 16, 2018.

In the case study, the authors report findings from a comparability assessment of epoetin alfa before and after a proposed manufacturing process change for which, they say, nonclinical assessment of structure-function relationships were not sensitive enough to identify clinically relevant differences resulting from differences in the drug’s glycosylation profile.

Over 370 centrally authorized products have been transferred to new rapporteurs located in the remaining 27 EU member states, Iceland, and Norway. The transfer followed a procedure developed by the EMA’s working groups on committees’ operational preparedness for both human and veterinary medicines in the wake of the United Kingdom’s withdrawal from the European Union.

The FDA has finalized its guidance on the Center for Drug Evaluation and Research and the Center for Biologics Evaluation and Research special protocol assessments (SPA). SPA is a process in which product sponsors may ask to meet with FDA to reach an agreement on the design and size of clinical trials and clinical or animal studies to determine whether they adequately address the scientific and regulatory requirements to support eventual marketing approval.

As nations around the world seek to reap the rewards of biosimilar savings, some countries, including Colombia, are updating their regulatory processes to better facilitate the introduction of biosimilars. A paper, recently published in the Generics and Biosimilars Initiative Journal, outlines the new landscape for biosimilar products in Colombia.

On Thursday, Leah Christl, PhD, director of the therapeutic biologics and biosimilars staff at the Center for Drug Evaluation and Research’s (CDER) Office of New Drugs at the FDA, hosted the organization’s first “Ask Me Anything” session about biosimilars on the website Reddit. Christl responded to user questions about the biosimilar approval process, the differences between a biosimilar and an interchangeable product, and pricing.

The Center for Biosimilars® recaps the top 5 biosimilars articles for the week of April 9, 2018.

Mylan's president, Rajiv Malik, said during the company's Investor Day, "If we don’t have a product and the market needs it, we’ll go and find it. Rituximab for Europe is a good example, we didn’t have it in the portfolio for either Biocon or Momenta, but we could find an opportunity…we’ll continue to do this; go out and keep on looking if there are gaps.”

Limited distribution networks, which are established when a drug maker contracts with either 1 or a limited number of distributors, can allow a manufacturer to efficiently manage the supply chain for a given product. However, as a recent paper argues, LDNs can have an anticompetitive impact on the marketplace.

The financial plan, which is revised each year, outlines the financial position of the Biosimilar User Fee Act program over the next 5-year authorization period, and explains how the FDA will allocate resources to build its biosimilars review program.

The Center for Biosimilars® recaps the top 5 biosimilars articles for the week of April 2, 2018.