News

The interchangeable designation allows pharmacists more flexibility to dispense this potentially money-saving product and gives Boehringer Ingelheim a marketing edge.

Here are the top 5 biosimilar articles for the week of October 11, 2021.

Investigators said the RAAS study filled in missing information on the value of dose modulations and infusion interval changes for patients with ankylosing spondylitis (AS) treated with CT-P13 (Remsima, Inflectra).

An interactive tool from Biosimilars Forum, an industry group, uses data from Pacific Research Institute to calculate potential biosimilar savings based on 75% market share.

The Center for Biosimilars® speaks with Polpharma Biologics executives Alex Moulson, vice president of Development, and Pawel Lewinski, head of Portfolio and Commercial Strategy, about the company's biosimilar pipeline.

The European Commission is collecting comment on its multifaceted blueprint for broadening access to biologics and generic drugs and stimulating competition.

Ivo Abraham, PhD, a professor with University of Arizona Health Sciences in the Department of Pharmacy Practice, outlines the current trajectory and savings potential for granulocyte-colony stimulating factor (G-CSF) biosimilars and Neulasta Onpro (pegfilgrastim).

Biosimilar development companies report an approval in Canada and positive phase 3 findings in China for their bevaciumab biosimilars.

Here are the top 5 biosimilar articles for the week of October 4, 2021.

A US District Court in Illinois has ruled that although trade secret theft may have occurred over an adalimumab biosimilar candidate, it happened far from the state. With only a very "attenuated" connection, there are no grounds to bring action against Alvotech in the case of purloined manufacturing data, the judge stated.

The court battle between AbbVie and Alvotech could be a defining victory in the struggle to bring biosimilar versions of adalimumab to market, but a yearlong court process must play out first.

Positive findings for Coherus BioSciences' ranibizumab candidate (CHS-201) were presented at the Scientific Meeting of the Retina Society, and the company said equivalence end points were met for an on-body injector version of Udenyca (pegfilgrastim).

Preventing the nocebo effect requires a demonstration of confidence in biosimilars from all health care practitioners, including pharmacists, experts said in a newly published rheumatology treatment guidance document.

Studies of the infliximab biosimilar Remsima in patients with inflammatory bowel disease were presented at United European Gastroenterology Week 2021.

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.