Regulatory

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.

Today, Celltrion announced that the FDA has issued Complete Response Letters (CRLs) for 2 of its products, CT-P10, a proposed rituximab biosimilar referencing Rituxan, and CT-P6, a proposed trastuzumab biosimilar referencing Herceptin.

Yesterday, the European Medicines Agency (EMA) opened a public consultation period concerning the European Union’s template for Good Manufacturing Practice (GMP) noncompliance statements. The EMA says that its GMP Inspectors Working Group is considering which actions will be required after an inspection concludes that a manufacturing site does not comply with GMP, especially in cases in which a statement of noncompliance could lead to a shortage of critical medicines.

The Center for Biosimilars® recaps the top 5 biosimilars articles for the week of March 26, 2018.

One of the more serious concerns the FDA has discussed is the possibility that a developer of a proposed biosimilar could be deterred from seeking approval of its product, because United States Pharmacopeial Convention's (USP) proposed changes could complicate the licensure of a proposed biosimilar that meets the approval requirements of the FDA but does not match the USP’s standards of a monograph.

FDA Commissioner Scott Gottlieb, MD, indicated that the agency would be putting forward policies that would compel branded drug makers to “tighten up their manufacturing, to have less variance of their biologics that are currently on the market.” In theory, this change could make it easier to develop a biosimilar using smaller studies.

The biosimilar insulin will be sold under the brand name Semglee in a 100 IU/mL 3mL prefilled pen presentation in both territories. Mylan and Biocon say that they plans to launch the product in various markets in Europe in the second half of 2018, and in Australia “later this year.”