Skylar Jeremias

German biopharmaceutical company Formycon has postponed its annual meeting due to the coronavirus disease 2019 (COVID-19) pandemic.

Coherus Biosciences, of Redwood City, California, sees continued profitability, thanks largely to sales of its pegfilgrastim biosimilar, Udenyca, launched in January 2019.

Molly Burich, head of public policy for Boehringer Ingelheim, a global drugmaker, discusses hopeful signs that the biosimilar market in the United States is improving.

Expanding access to biosimilar pegfilgrastim (Ziextenzo) for patients at intermediate risk of febrile neutropenia and converting patients at high risk who are on the reference product (Neulasta) could save millions in healthcare costs, according to new study results.

Interest in tocilizumab has grown lately as Roche has a clinical trial underway to evaluate efficacy in coronavirus disease 2019 (COVID-19)–related pneumonia.

A new study found that office-based providers, especially those with large practice sizes, were earlier and quicker at adopting biosimilar filgrastim (Zarxio) than hospital-based providers.

Mylan and Biocon have launched their pegfilgrastim biosimilar, Fulphila, in Canada for the treatment of febrile neutropenia, a condition of low white blood cell count, as a result of chemotherapy.

A retrospective, postmarketing study demonstrates higher incidence of joint and bone pain, neutropenia with certain filgrastim biosimilars, compared with Neupogen.

Although the coronavirus disease 2019 (COVID-19) pandemic has put a burden on the economy and the healthcare system in particular, Kashyap Patel, MD, believes that the crisis will likely speed up biosimilar uptake in the United States.

A peer-reviewed study suggested that comparative efficacy trials are not always needed to determine efficacy equivalence for biosimilars, as data from pharmacokinetic (PK) studies and in vitro functional assays may suffice.

Posters presented at the Academy of Managed Care Pharmacy (AMCP) eLearning Days meeting this week from April 20 to 24 reveal important data on biosimilar utilization management, switching, and affordability.

A pathway model that incorporated use of biosimilars has shown great promise, according to Colin C. Edgerton, MD, executive chairman of the American Rheumatology Network.

Education is often noted as a barrier to uptake, but a prominent pharmacy expert said multiple private and public policies also stand between patients and biosimilars.

A commentary in The Lancet suggests that the new biological pathway for insulin product approval, established in March, will be insufficient to address issues insulin prices and biosimilar uptake.

The private payer lobby America’s Health Insurance Plans has issued a laundry list of things the FDA and Federal Trade Commission could do to improve biosimilar access.

The Boston Medical Center Health System (BMCHS) of Massachusetts was able to achieve high adoption rates for biosimilars based on experience with a “nonbiosimilar.”

Russia has rebuilt its pharmaceutical industry following the demise of the former Soviet-led government, and emerging companies such as Geropharm are looking for markets abroad.

Biosimilar companies may do themselves a disservice if they produce education materials that don’t address the needs of clinicians or blatently self-promote, according to Kathy Oubre, chief operations officer at Pontchartrain Cancer Center of Louisiana.

Because they will see greater savings, employers have greater incentive to embrace biosimilars than plan sponsors in the overall insured population. Employers can be advocates for policy changes that promote biosimilars by contacting legislators; they can organize email campaigns to reach lawmakers more easily.

The National Comprehensive Cancer Network (NCCN) Guidelines may help get biosimilars into circulation because the NCCN will recommend them for off-label uses.

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.

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.

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.

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.

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.

“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.

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.

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

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.