News

Kirollos Hanna, PharmD, from the University of Minnesota Medical Center, talks about the savings that biosimilars have brought to his practice and how he tackles patient and physician concerns over whether biosimilars work as well as reference products.

The Center for Biosimilars® Advisory Board member Sarfaraz K. Niazi, PhD, explains an “against the grain” approach to tapping unmet need and revenue potential in biosimilars.

Here are the top 5 biosimilar articles for the week of September 27, 2021.

Adrian van den Hoven, director general for Medicines for Europe, and Diogo Piedade, market access manager for Medicines for Europe, analyze findings from the group's recent survey of European biosimilar markets.

Sonia T. Oskouei, PharmD, BCMAS, DPLA, the vice president of Biosimilars at Cardinal Health, discussed the many ways that pharmacists and interchangeability designations can affect biosimilar utilization.

Adrian van den Hoven, director general for Medicines for Europe, and Diogo Piedade, market access manager for Medicines for Europe, discuss the group’s recent EU report: Market Review—Biosimilar Medicine Markets.

The month of September 2021 was chock-full of biosimilar news. From regulatory actions to policy initiatives to clinical news, no dust was gathering on the road toward wider biosimilar adoption.

As COVID-19 cases continue to rise in many states, Kashyap Patel, MD, CEO of Carolina Blood and Cancer Care Associates, provides insight into how biosimilar pegfilgrastims can help reduce costs; however, not all payers are on board.

Biosimilar User Fee Act reviews have been slowed by the pandemic and the FDA has opened a public comment period as it plots the course through 2027.

The first ranibizumab biosimilar (Byooviz) has potential to alleviate financial burden associated with retinal conditions, but may not be the only new approval for ophthalmology treatment in 2022, explains Sonia T. Oskouei, PharmD, BCMAS, DPLA, vice president of biosimilars for Cardinal Health.

Here are the top 5 biosimilar articles for the week of September 20, 2021.

The Center for Biosimilars® spoke with George Williams, MD, clinical spokesperson for the American Academy of Ophthalmology (AAO), about the FDA’s recent approval of Byooviz (ranibizumab), the first biosimilar specifically approved for treatment of eye diseases.

In a biosimilar trend report, Amgen discusses marketing achievements, US biosimilar policy, payer and provider acceptance of these agents, and the outlook for further growth.

The HHS plan ordered up by President Biden for combatting high drug prices is a hodgepodge of ideas that have long circulated in Washington, DC, but can any of them be made to stick? An intellectual property and FDA policy expert, Chad Landmon, JD, shares his perspective.

Reykjavik, Iceland company Alvotech said the FDA review of its adalimumab candidate is held up by pandemic-related curbs on overseas inspections.

Byooviz (ranibizumab) was approved for multiple ophthalmologic conditions, although market launch is at least 9 months away, owing to patent protections on the originator product.

Investigators said TX05 met pathologic complete response criteria for equivalence to the originator product, Herceptin. The biosimilar candidate also fell within objective response rate, immunogenicity, safety, and tolerability margins for similarity.

Kirollos Hanna, PharmD, from the University of Minnesota Medical Center, discusses some of the tactics that biosimilar companies are employing in order to level the playing field and better compete against originator companies.

According to a multiyear, retrospective study, filgrastim biosimilar Zarxio cost $20.50 more on average per administration than reference Neupogen in the hospital outpatient setting.

Alvotech gains an EU marketing recommendation for AVT02, a proposed adalimumab biosimilar; New Zealand may give preferential status to Amgen's adalimumab biosimilar; BioFactura looks to deliver ustekinumab via a robotic pill.

BCD-021 demonstrated equivalence in a phase 3 study involving Russian and Indian patients with advanced non–small cell lung cancer (NSCLC).

Here are the top 5 biosimilar articles for the week of September 13, 2021.

MIL60 bevacizumab biosimilar candidate demonstrates equivalence to the originator Avastin in a population of Chinese patients with non–small cell lung cancer (NSCLC) treated in a frontline setting.

The “patent dance” under the Biologics Price Competition and Innovation Act (BPCIA) is meant to resolve litigation efficiently, and it does, although in practice biosimilar developers and originator companies may not completely adhere to the prescribed steps, according to Biotechnology Innovation Organization (BIO) experts.

The positive findings for the trastuzumab biosimilar Ontruzant in patients with human epidermal growth factor receptor 2 (HER2)–positive early or locally advanced breast cancer were presented at the European Society for Medical Oncology (ESMO) Congress 2021.

The Alliance for Safe Biologic Medicines (ASBM) has fought since 2010 in opposition of payer policies that promote automatic switching to cheaper biologics including biosimilars. The group's new chair is no newcomer to this battle.

Companies that gain Drug Controller General of India (DCGI) marketing authorization are likely in for much more extensive trials if they hope to commercialize their biosimilars on the global platform.

Refinements to the analytical testing of biosimilar candidates to verify similarity were worked into 2019 guidance from the FDA. These changes offer what the author considers a more "rational approach."

Here are the top 5 biosimilar articles for the week of September 6, 2021.

The findings support Alvotech's bid for interchangeable status for the high-concentration, citrate-free adalimumab biosimilar candidate.