Regulatory

The Center for Biosimilars® recaps the top stories for the week of March 9, 2020.

In light of the COVID-19 outbreak, the FDA has suspended foreign inspections of FDA-regulated manufacturing plants and products. Meanwhile, escalating foreign travel restrictions put a damper on growth of the biosimilars industry.

The Center for Biosimilars® recaps the top stories for the week of March 2, 2020.

Looking to March 23, the FDA released a question-and-answer guidance document for industry about the upcoming transition for how certain products will now be approved under a biological pathway, including exceptions to the transition and how companies will receive notifications about their applications.

The FDA announced changes or updates to several policies. Chief among them: final guidance on a regulatory shift for insulin and certain other products.

The Center for Biosimilars® recaps the top stories for the week of February 24, 2020.

Ultimately, the Purple Book is supposed to include all Center for Biologics Evaluation and Research (CBER) and Center for Drug Evaluation and Research (CDER) regulated products, including transition biological products.

The FDA said it was no longer necessary to include the interpretation of the term “chemically synthesized polypeptide” as first proposed in December 2018.

The Office of Pharmaceutical Quality, charged with strengthening and building public trust in the US supply of medicine, notes that March 23, 2020, will mark a key turning point in the way that many biologics are licensed.

The agency will now review and act on original 351(k) biologics license application (BLA) supplements with clinical data within a 6-month time frame. Originally, such supplements had a 10-month goal date for review. In addition, applicants can now request the FDA refrain from taking action on supplements of 351(k) BLAs before a certain date.

The FDA and the Federal Trade Commission (FTC) will work more closely to support a more competitive market for biosimilars and interchangeable products. In addition, the FDA published draft guidance for industry about how to advertise and promote biologic products truthfully and announced a public workshop.

The European Medicines Agency’s Committee for Medicinal Products for Human Use recommended marketing authorization for Pfizer's Ruxience, a rituximab biosimilar.

The documents include specific ones for hemophilia, retinal disorders, and rare diseases, as well as manufacturing, testing, and patient follow-up.

An accompanying editorial describes the current regulatory process as “a thicket of special programs, flexible review criteria, and generous incentives,” and suggests starting points for reforms, including improving access to biosimilars.

In 2019 the FDA approved 48 novel drugs and 10 biosimilars, according to the Center for Drug Evaluation and Research (CDER).

In late December, Spectrum Pharmaceuticals announced that the FDA has accepted for review a Biologics License Application for eflapegrastim, a novel drug that could, if approved, compete with existing granulocyte colony-stimulating factor (G-CSF) therapies and their biosimilars.

Last month, Gilead Sciences submitted a New Drug Application (NDA) to the FDA for filgotinib under the priority review process. Filgotinib is a Janus kinase (JAK) inhibitor aimed at moderate-to-severe rheumatoid arthritis (RA).

When it comes to US biosimilars, 2019 was the busiest year yet for regulatory activity, with a bevy of new approvals and the publication of long-awaited guidance documents.

When it comes to US biosimilars, 2019 was a busy year for regulatory activity. This week on the podcast, we're rounding up the key developments of the year.

The Center for Biosimilars® recaps the top stories for the year 2019.

The Center for Biosimilars® recaps the top stories for the week of December 16, 2019.

The World Health Organization (WHO) this week prequalified its first biosimilar. The product, Samsung Bioepis’ biosimilar trastuzumab, Ontruzant, referencing Herceptin, could now become available to more patients with HER2-positive cancer in low- and middle-income countries.

Previously, such chemically synthesized polypeptide products were excluded from the regulatory transition, so subsequent-entry products referencing these drugs would not be eligible for biosimilars or interchangeable product approval. Such products would also not be eligible for generic drug development.

Looking at products that entered the marketplace between 2015 and 2017, an FDA report finds that greater competition among generic drug makers is associated with lower prices.

The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for Pfizer’s biosimilar adalimumab referencing Humira. The product, which Pfizer proposes to market under the name Amsparity, will now be reviewed by the European Commission before it receives final marketing authorization.

On Thursday, the Senate voted to confirm Stephen Hahn, MD, FASTRO, chief medical executive at the University of Texas MD Anderson Cancer Center, as the 24th commissioner of the FDA.

The FDA has approved Amgen’s infliximab biosimilar, Avsola (infliximab-axxq), referencing Remicade.

The Center for Biosimilars® recaps the top stories for the week of December 2, 2019.

The Center for Biosimilars® recaps the top stories for the week of November 25, 2019.

Biocon announced today that its supplemental Biologics License Application (sBLA) for its biosimilar pegfilgrastim, Fulphila, filed with partner Mylan, has been approved by the FDA.