Regulatory

A new paper argues that the addition of a single data element—namely, a batch or lot number—would enhance the value of pharmacovigilance systems for biosimilars.

The Center for Biosimilars recaps the most-read articles of 2017.

The Center for Biosimilars recounts 4 of the top legal developments in the biosimilars space during 2017.

In clinical practice, biologics are routinely used for medically accepted off-label indications, and these uses are typically curated by guidelines. A newly published study, led by Edward Li, PharmD, MPH, BCOP, argues that the FDA’s framework for granting the extrapolation of indications for biosimilars can be used by clinicians and payers to determine appropriate off-label uses of biosimilars.

2017 brought a number of notable guests to The Center for Biosimilars®. Here are the most-watched interviews of the year.

The United States now has 9 FDA-approved biosimilars. Our latest infographic breaks down what you need to know about these products.

The European risk management plan (RMP) contains relevant safety information for specific products, with characterizations of both potential and identified risks, including real-world data. Because the RMP is systematically updated, the RMP can provide early indications of differences in product safety between originator and biosimilar therapies.

The Center for Biosimilars recaps the the top 5 articles for the week of December 18, 2017.

The US Government Accountability Office (GAO) reports that retail drug spending accounted for about 12% of total personal healthcare service spending in the United States in 2015, up from about 7% through the 1990s.

Biologic drugs play a key role in the US healthcare market, as they are often the standard of care for treating complex diseases, many of which require long-term treatment. With the FDA’s approval of biosimilars of several important biologic treatments, and with a significant pipeline of biosimilars still in development, it is expected that many biosimilars will be introduced to the US market in the next several years.

On December 19, Richard Seeborg, US district judge for the Northern District of California, granted a summary judgment of noninfringement in Amgen v Sandoz.

Last week’s ruling in the federal circuit, which held that state law cannot compel biosimilar applicants to participate in the Biologics Price Competition and Innovation Act (BPCIA) “patent dance,” has raised questions about how the case will impact the BPCIA in the days ahead. Yet Kevin M. Nelson, JD, partner at Schiff Hardin’s Hatch-Waxman and biosimilars practice, told The Center for Biosimilars® in an interview, that, “For the BPCIA, I don’t think it means much.” In Nelson’s view, the most significant impact that the ruling will have is on the early case assessments that biosimilar applicants undertake when determining whether they will take part in the information exchange process.

Republic of Korea-based Samsung Bioepis announced on Tuesday that the FDA has accepted for review the company’s Biologics License Application (BLA) for SB3, a proposed trastuzumab biosimilar, referenced on Herceptin. If the FDA approves SB3, the drug will be commercialized in the US by Merck.

Fresenius Kabi, a subsidiary of the German-based Fresenius SE and Co. KFaA, announced yesterday that its Marketing Authorization Application for MSB11022, an adalimumab (Humira) biosimilar candidate, was submitted and accepted for review by the European Medicines Agency (EMA).

Scott Lassman, JD, partner in Goodwin's Technology and Life Sciences Group, explains why REMS programs give biosimilar and generic drug developers cause for concern.

Frank Dellanna, MD, and colleagues reviewed the journey of HX575 from development to approval in Europe, and describe a decade of clinical experience in patients with CKD, as the history and experience with this biosimilar provides an excellent example of a successful demonstration of biosimilarity.

Republic of Korea-based biosimilar developer Celltrion announced on December 16 that it has received a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) for its trastuzumab biosimilar, referenced on Roche’s blockbuster anticancer therapy, Herceptin. The positive opinion will now be referred to the European Commission for final review.

Scott Lassman, JD, partner in Goodwin's Technology and Life Sciences Group, explains why Citizen Petitions to the FDA are so controversial among generic and biosimilar stakeholders.

The FDA has released new draft guidance for industry on refuse-to-file (RTF) action taken by the FDA. The document seeks to clarify circumstances under which the FDA’s Center for Drug Evaluation and Research (CDER) may refuse to file a new drug application (NDA), supplemental NDA, or a Biologics License Application (BLA), or supplemental BLA for a product regulated by CDER.

The Center for Biosimilars® recaps the top 5 articles for the week of December 11.

Pfizer announced on December 13 that the FDA has approved Ixifi, PF-06438179, infliximab-qbtx, the company’s second biosimilar to the reference infliximab, Remicade.

On December 13, the House of Representatives Committee on Energy and Commerce’s Subcommittee on Health heard testimony from a variety of healthcare stakeholders in a hearing titled “Examining the Drug Supply Chain.” During the proceeding, a follow-up to a hearing on implementation of the 21st Century Cures Act, several witnesses focused their attention on the promise of—and challenges specific to—biosimilars in the US marketplace.

Roche has announced positive data on 2 of its innovator oncology biologics in combination with other therapies. The combinations using rituximab (MabThera, Rituxan) and bevacizumab (Avastin) could help the Swiss drug maker to protect sales of these monoclonal antibodies in the face of oncoming biosimilar competition.

The FDA has granted final approval to the first short-acting follow-on insulin product, Sanofi’s Admelog (insulin lispro injection). Admelog is indicated to improve insulin control in blood sugar levels in adults and children aged 3 years and older who have type 1 diabetes and in adults who have type 2 diabetes.

Evaluate Group’s EP Vantage pharma and biotech preview of 2018 predicts that the uptick in the pharmaceutical and biotech sectors that occurred in 2017 is likely to continue into 2018.

While the American College of Rheumatology praised the FDA for considering ways to reduce regulatory burden, the organization called on the FDA to focus on 6 “minimum components of review and oversight” for biosimilars.

Republic of Korea-based biopharma company Celltrion is looking to accelerate its momentum in Europe; analysts belive that the company could receive the European Medicines Agency’s (EMA) approval to market its biosimilar of Roche’s blockbuster cancer treatment, Herceptin (trastuzumab), by March 2018.

This week, Leah Christl, PhD, associate director for therapeutic biologics, Center for Drug Evaluation and Research (CDER), FDA, and Sue Lim, MD, medical officer at the FDA’s Office of New Drugs, held a webinar to discuss the regulatory framework for biosimilars as well as the development and approval process for these drugs.

The Center for Biosimilars recaps the top 5 articles for the week of December 4.

USV has announced that the European Medicines Agency (EMA) has accepted for review its application for a proposed pegfilgrastim biosimilar.