News

Two doctors call for interchangeability requirements for biologics to be waived for insulin products under the new regulatory pathway under the Biologics Price Competition and Innovation Act (BPCIA) of 2009.

China is getting the hang of producing biosimilars, and harvest time is on the near horizon, according to a new report.

Mylan and Lupin have gained the necessary recommendation to begin marketing their etanercept biosimilar in Europe.

Because biosimilars piggyback on much of the clinical work already done on the drugs they imitate, they can be brought to market for less money, and therein lies the savings potential for patients and health systems, according to Lee S. Schwartzberg, MD.

The Center for Biosimilars® recaps the top stories for the week of March 23, 2020.

Alvotech Hf and DSH hope to get an adalimumab biosimilar approved in the United States, Europe, and selected Southeast Asia markets.

When providers get used to biosimilars, they tend to prescribe them exclusively, according to a study in The American Journal of Managed Care.

Teva Pharmaceuticals USA has filed suit in an attempt to use the expanded biologics licensure pathway as a way to hold back a potential competitor.

Life under the new biologics pathway will be easier for some drugs than others, notes Stacie L. Ropka, PhD, JD, a patent attorney with Axinn, Veltrop & Harkrider LLP, in Hartford, Connecticut.

“We're always under the tyranny of the 10-year budgetary window that the CBO [Congressional Budget Office] models under,” said Rep. Michael C. Burgess, MD, R-Texas, in a discussion of the limitations of the US system for bringing biosimilars to the market.

A gentle, persuasive effort to get patients and physicians to adopt biosimilars is likely to work better than a heavy-handed approach, say Canadian investigators, who recommend more study of how mindsets and prescribing practices are changed.

The FDA has approved a multidose vial of Samsung Bioepis’ trastuzumab biosimilar Ontruzant, which was first approved as a 150-mg single-dose vial in January 2019 and has yet to reach the US market in either form.

As coronavirus disease 2019 (COVID-19) causes medical systems to bog down from a host of related issues, a UT Health expert said clinical trials likely will be powered down and hospitals will put consideration of newly available agents on hold.

Competition in the insulin market is expected to rise because insulin products will be approved under the regulatory pathway for biological products now that the transition period added to the Biologics Price Competition and Innovation Act (BPCIA) of 2009 has officially ended, the FDA said.

As of today, the FDA has completed a 10-year process to bring a wider set of biologics under the biologics license pathway for approval.

The American College of Rheumatology (ACR) has issued a list of recommendations for streamlining prior authorization to eliminate redundancy and improve access for patients.

Kashyap B. Patel, MD, has worn many hats in the struggle to broaden biosimilar access. He is an independent oncology practitioner, a member of the Community Oncology Alliance (COA), and a representative of International Oncology Network (ION) Solutions, a large drug purchasing organization. Bringing biosimilars to a broader population of patients has involved negotiations with payers, persistence on Capitol Hill, and education, he explains in an interview.

Oncology supportive care, oncology, and immunology biosimilars make up the 3 main classes of biosimilars that have emerged on the US market. However, rates of uptake are vastly different owing to a variety of factors.

The Center for Biosimilars® recaps the top stories for the week of March 16, 2020.

Sheila Frame, US head of Marketing and Market Access and Patient Services for Sandoz, discusses her company’s growing portfolio, the pipeline of biosimilar drugs, and the need for a more robust biosimilars market in the United States.

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).