Regulatory

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 In addition, the FDA published draft guidance for industry about how to advertise and promote biologic products truthfully and announced a public workshop.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.

Celltrion Healthcare announced that the European Commission has authorized Remsima SC, a subcutaneously administered formulation of its biosimilar infliximab, CT-P13, for the treatment of rheumatoid arthritis. The product is the first subcutaneous infliximab option to be approved in any regulatory territory.

The FDA today released draft guidance for industry on clinical immunogenicity considerations for biosimilar insulins and interchangeable insulins. The guidance document provides recommendations as to whether—and when—comparative clinical immunogenicity studies will be needed to support an application to the FDA for insulin products under the biosimilar approval pathway.

In an interview with The Center for Biosimilars®, Sandoz’s Sheila Frame, MBA, vice president of marketing, market access, and patient services, and William Yoon, PharmD, MBA, head of external engagement and medical advocacy, reflected on the past decade of experience with the biosimilar pathway and gave a look at the future of Sandoz’s biosimilar efforts.

The Center for Biosimilars® recaps the top stories for the week of November 18, 2019.

President Trump’s choice to lead the FDA faced some questions, but not many, about drug pricing, according to various press reports about the Senate committee hearing Thursday regarding the nomination of Stephen Hahn, MD, FASTRO, the chief medical officer of MD Anderson Cancer Center.