News

Two new bills aimed at increasing access to biosimilars and saving billions of dollars in out-of-pocket costs have been introduced in Congress. Both have been referred to committees for further review.

A review article contends that providers need to know more about the approval process for biosimilars and what data points are examined.

In guidance issued specifically in response to the COVID-19 pandemic, the FDA has advised that clinical trial protocol modifications may be made but must be documented and reported as promptly as possible. The FDA notes that trial participants may be sickened by COVID-19, supplies of investigational drugs may be interrupted, and quarantines and closings may make on-site patient visits impossible.

As the coronavirus (COVID-19) pandemic unfolded and disrupted pharmaceutical production, a panel of experts advocated for better education and legislation surrounding biosimilars in order to improve uptake in the United States and create affordable alternatives for patients.

The Congressional Budget Office has estimated that the Grassley-Wyden bill regulating pharmaceutical prices would generate savings of more than $94 billion over the next decade.

Schiff Hardin patent attorney Imron T. Aly works with India-based manufacturers of biologics and says supply chain problems are anticipated shortly in the United States, based on FDA inspection policy and sourcing issues.

In inflammatory rheumatic diseases, the nocebo effect may account for a portion of treatment failures among patients who were placed on biosimilars; however, discontinuations due to the nocebo effect can be difficult to diagnose due to the absence of diagnostic criteria, differences in pathologic backgrounds for each disorder, and the absence of specific neurochemical and neuroimaging studies, investigators found.

Teva Pharmaceuticals USA and Celltrion Healthcare have launched the fourth trastuzumab biosimilar, Herzuma, at a 10% discount to the cost of reference product Herceptin.

Supplies of active pharmaceutical ingredients (API) are difficult to track and anticipate owing to limited information that manufacturers are required to provide, an issue that can make it difficult to respond to the COVID-19 pandemic, according to an interview with a Vizient executive.

Seen up close, many patents are not truly strong enough to block biosimilar commercialization, although patents filed after FDA approval of originator products can bar access to modern manufacturing methods, according to Hans Sauer, deputy general counsel and vice president for intellectual property at the Biotechnology Innovation Organization (BIO).

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.