Regulatory

Certain biosimilar studies are performed out of an abundance of caution and good marketing sense, although science has leapfrogged the need for these trials, panelists said at the Terrapinn Festival of Biologics Basel 2020.

Manufacturers, not regulators, may be the holdouts when it comes to eliminating comparative clinical efficacy trials, according to experts interviewed by The Center for Biosimilars®.

Companies continued to prove in October that rare regulatory approvals and a pandemic have not stopped them from moving forward with plans to further products and search for ways to save money.

The FDA may require comparative clinical efficacy for biosimilar approval, but on top of all the other required and available evidence, these trials add little value, Sarfaraz K. Niazi, PhD, states.

A collaboration with the FDA could lead to new forms of pharmacodymamic measurement that improve speed and efficiency of biosimilar development and approval.

Amgen said its sales results for Mvasi (bevacizumab) and Kanjinti (trastuzumab) give it confidence that the US market for biosimilars is more viable than generally perceived.

Arnold Ventures suggests ways the FDA and other governmental entities can get more biosimilars into circulation, faster.

A trio of legal experts discuss Amy Coney Barrett's bid for a Supreme Court seat and how that might affect deliberations on the Affordable Care Act and the Biologics Price Competition and Innovation Act (BPCIA).

Biocon had a busy quarter, which included the launch of a long-acting insulin glargine product (Semglee) in partnership with Mylan.

Earnings fell overall for Biogen, although biosimilar revenues continued an upward climb.

Shanghai Henlius Biotech will share development and distribution of its bevacizumab biosimilar candidate HLX04 with Zhuhai Essex and Essex Bio-Investment.

An Avalere analysis suggests costs are more moderate and lower under a no–step therapy scenario for patients with Crohn disease.

Amgen's 2020 biosimilar report goes into detail on market share and costs for biosimilars across the therapeutic spectrum in the United States.

Alexion and Celltrion separately announce advances in their drug development and marketing efforts.

Years ahead of patent expirations for programmed death-1 (PD-1) inhibitors, biosimilar companies have begun focusing on these targeted drugs.

Average clinical efficacy testing cost millions of dollars more for phase 3 biosimilar studies than for pivotal studies of originator products, authors report.

As the United States continues to struggle to increase biosimilar uptake, presenters at the DIA 2020 Biosimilars Conference offered insight into what other countries have done to encourage biosimilar use.

Simplified standards for biosimilar approvals in the United Kingdom may open the door to broader changes.

The FDA has had to rely on triaging to address its most critical priorities during the unfolding coronavirus disease 2019 (COVID-19) pandemic, according to Peter P. Stein, MD.

A report from the IQVIA Institute for Human Data Science states that assessments of the health of the US biosimilar market are too conservative.

The European Medicines Agency (EMA) regulatory review advances a pact between Samsung Bioepis and Biogen announced last year.

Researchers contend the "totality of evidence" for biosimilar approval may be sufficient to demonstrate interchangeability.

Accord brought 2 biosimilars referencing blockbuster oncology products to the United Kingdom and amended its agreement with Shanghai Henlius Biotech.

Biosimilars could improve health system sustainability in Slovakia; however, of the 54 biosimilars approved by the European Medicines Agency as of August 2019, fewer than half are available in Slovakia

September saw several biosimilar regulatory advances despite 2020 being a slow year for biosimilar approvals and launches.

The Federal Trade Commission's powers to bring antitrust actions are circumscribed by public versus private and what is vs isn't "reasonable," Markus H. Meier explained.

An advance is notched for the ravulizumab (Ultomiris) follow-on product from Alexion. Clinical findings in atypical hemolytic uremic syndrome (aHUS) are provided.

Debra Patt, MD, PhD, MBA, discusses issues affecting biosimilar uptake at the Patient-Centered Oncology Care® 2020 virtual conference.

Despite concerns over whether importing drugs from Canada would be safe for patients or effective at lowering drug costs, the FDA has moved forward with implementing the policy.

The International Generic and Biosimilar Medicines Association (IGBA) seeks to limit the use of comparative clinical efficacy studies to support biosimilar equivalency applications.