News

China’s National Medical Products Administration (NMPA) has accepted Henlius Biotech’s new drug application for its denosumab biosimilar, hlx14.

Following close on the heels of its US approval for Ruxience (rituximab), Pfizer has gained the European Commission nod and aims to launch in coming months.

Amid the coronavirus disease 2019 (COVID-19) pandemic, the FDA issued guidance stressing the importance that manufacturers notify it of discontinuations and manufacturing interruptions so that the agency can implement contingency measures.

The coronavirus disease 2019 (COVID-19) effect on the biosimilar industry will be deep and lasting, causing not just approval and launch delays but profound structural changes in how business is done.

Self-insured companies could have saved $407 million to $1.4 billion in 2018 had they switched completely from reference biologics infliximab and filgrastim to biosimilars.

After a number of issues raised by the FDA about plant quality, Biocon has gotten clearance for its Malaysia insulin plant and now awaits FDA marketing authorization for Semglee, its insulin glargine agent.

During March, the FDA worked to mitigate drug quality issues potentially arising from the coronavirus disease 2019 (COVID-19) pandemic, established a new regulatory pathway for certain biologics, and launched a high-profile effort with the Federal Trade Commission to halt anticompetitive practices.

So many factors have the potential to affect the quality and performance of biosimilars that clinicians must be aware of the need for constant pharmacovigilance.

Russian company Biocad gains distribution rights for its rituximab and trastuzumab biosimilars in Bosnia and Herzegovina.

Canadian provinces encounter opposition in their move to implement forced switching of patients from reference products to biosimilars.

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.