News

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

Even as the first bevacizumab biosimilar gained approval for marketing in China, data emerged from a phase 1 pharmacokinetic study comparing the biosimilar with its reference product (Avastin).

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.

Stakeholder comments at a biosimilars forum staged by the FDA and Federal Trade Commission focused on improving the quality of information being disseminated about biosimilars and the need to make the approval process less burdensome for manufacturers.

As regulators work to increase competition and lower costs in the insulin market, CMS has released a new Medicare model intended to lower co-pays for insulin products to a maximum of $35.

HHS Secretary Alex Azar discussed the future of biosimilars in the United States and the actions taken to ensure reductions in healthcare and prescription drug costs at the Biosimilars: Breaking Through the Barriers symposium in Washington, DC.

Two regulatory experts said in an editorial that suffixes for biosimilars can support adverse event reporting and build provider and patient confidence in biosimilars.

The conference was designed to further collaborative efforts between the FDA and the Federal Trade Commission (FTC) and generate public confidence in regulators’ commitment toward fostering a healthy biosimilars marketplace, but the goal is not to put manufacturers of innovator biologics on edge, said Stephen M. Hahn, commissioner of the FDA.

The FDA granted the application for the biosimilar to Avastin a decision date of December 27, 2020.

There are several pending legislative proposals in both the House of Representatives and the Senate designed to encourage more commercialization of biosimilars, but the 2020 election may determine their timing.

Although biosimilar insulins are available in Europe, there are none in the United States currently, although that is slated to change.

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

Only 24% of providers were comfortable with prescribing biosimilars for patients with inflammatory bowel disease (IBD).

Growing awareness of biosimilars, patent expirations, and demands to lower healthcare costs are combining to increase uptake over the next 3 to 5 years, according to a recent S&P Global Ratings report. Some pharamceutical firms stand to gain, while others are more exposed.

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.

Both the capitalized research and development costs as well as the average cost of investments were higher than previous estimates from other researchers.

The Supreme Court will hear an appeal by a coalition of 20 mainly Democratic states, which are hoping for a reversal of a Fifth Circuit Court of Appeals ruling that held the Affordable Care Act’s (ACA) individual mandate is unconstitutional and called into question whether the remaining provisions of the law could still stand. However, a decision will not come until after the November 2020 presidential election.

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.

Depending on the outcome, 3 major biosimilar antitrust actions, as well as a related Federal Trade Commission investigation, could significantly change how biologics are priced.

This is the third Form 483 Biocon has received for the insulin plant in 3 years.

The quantitative comparison study compared 4 different, commercially available enzyme-linked immunosorbent assays used in therapeutic drug monitoring to detect drug concentration and antibodies to infliximab in samples of drug diluted in serum.

Lichen planopilaris (LPP) is a type of scarring hair loss that occurs when lichen plaus, a relatively common inflammatory skin disease, affects areas of skin where hair grows. It destroys the hair follicle and replaces it with scarring, resulting in permanent hair loss. LPP’s causes and pathology are unknown.

The use of low-dose methotrexate in rheumatoid arthritis dates back more than 30 years, but despite these decades of clinical use, data on adverse effects have come mostly from observational studies rather than randomized controlled trials (RCTs), the authors say.

Antitrust claims are a product of federal statute, said the Third Circuit Court of Appeals, in reinstating a Walgreens and Kroger antitrust lawsuit against J&J over its branded infliximab, Remicade.

The study compared the stool samples of patients with ulcerative colitis (UC) with patients with familial adenomatous polyposis. Both groups may have colectomies, but only the patients with UC have inflammation that may return even after surgery.

The guidelines, based on clinical evidence, are a pathway to a shared decision-making process between patients and their physicians, said the American College of Rheumatology (ACR).

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.

A recent year-in-review article outlines studies published in 2019 about nonmedical switching from originator biologics to biosimilars in rheumatoid arthritis, psoriatic arthritis, and axial spondyloarthritis.

The Center for Biosimilars® recaps the top stories for the week of February 17, 2020.