News

Trials for denosumab biosimilars are ramping up and researchers are concerned whether patients with cancer switching to biosimilars have been adequately informed beforehand.

Jim Carey, head of US policy and government relations at Organon, a spinoff company from Merck, breaks down strategies to push forward biosimilar legislation, the anticipation for adalimumab biosimilars, and more in this multi-part interview.

Results from a phase 3 trial suggested similar efficacy and safety of the denosumab biosimilar candidate Arylia (AryoGen Pharmed) to the reference product (Prolia) in postmenopausal osteoporosis.

Here are the top 5 biosimilar articles for the week of July 25, 2022.

Biocon’s revenues for the quarter were up by 23% from last year, thanks to the success the company has had with biosimilars, of which revenues increased by 29%, and generic drugs, which had an increased revenue of 19%.

The deal follows a string of trials and settlements totaling $550 million in separate cases around the country.

Prestige Biopharma and Intas Pharmaceuticals join forces to partner on a bevacizumab biosimilar for multiple countries, and Hikma Pharmaceuticals makes a deal with Celltrion Healthcare for the commercialization of an adalimumab biosimilar.

Sandoz’ applications for its Tysabri biosimilar (natalizumab) and its high-concentration version of its Humira biosimilar (adalimumab) were accepted for review by the FDA and the European Medicines Agency.

On this podcast episode, The Center for Biosimilars spoke with Chronis Manolis from UPMC Health Plan to discuss how health care policies may shift as adalimumab biosimilars referencing Humira come to market in 2023, including how providers and payers can ensure equitable access.

Here are the top 5 biosimilar articles for the week of July 18, 2022.

In recent weeks, Celltrion Healthcare furthered its adalimumab biosimilar (Yuflyma) by launching the drug in Spain and Portugal and starting a clinical trial in France while Xbrane Biopharma provided an update on the FDA filing of its ranibizumab biosimilar.

The biosimilar candidate would reference Prolia, used in the treatment of osteoporosis in postmenopausal women and to treat bone loss in adult men and women who are at increased risk of fracture. It is also planned as a biosimilar for Xgeva, which is indicated to prevent skeletal fractures in patients with cancer.

Posters from the American Society of Clinical Oncology’s annual meeting showed the safety and efficacy of a trastuzumab biosimilar and a denosumab biosimilar in different types of cancer.

Two experts in biosimilar intellectual property (IP) law break down the issues that digital health and precision medicine face with IP and the history of case law that has created the current landscape.

Julie M. Reed, the executive director of the Biosimilars Forum, dives into the efforts that the Forum is taking to ensure that FDA can catch up on their inspections backlog and get biosimilar approvals back on track.

A real-world study on Pfizer and Celltrion Healthcare’s infliximab biosimilar (infliximab-dyyb, Inflectra; CT-P13) demonstrated positive clinical and patient-reported outcomes in patients with inflammatory bowel disease (IBD) in the United States and Canada.

Here are the top 5 biosimilar articles for the week of July 11, 2022.

Abstracts from the European Hematology Association Congress 2022 confirmed comparable safety and effectiveness profiles between 2 rituximab biosimilars and the reference product (Rituxan) in patients with large B-cell lymphoma.

Amgen's early view said health care savings from the use of these biologic therapies climbed to $3 billion in the second quarter of 2022, for total of $18 billion over the past 6 years.

A letter penned by Sarfaraz K. Niazi, PhD, advocating for the banning of animal testing requirements for biosimilar development was published in Science, suggesting the journal has softened to the idea that animal testing may not be as useful as originally thought.

Ivo Abraham, PhD, chief scientist of Matrix45 and a member of The Center for Biosimilars® Advisory Board, explains the difference between biosimilar interchangeability and substitution and weighs in on whether switching studies are necessary.

On this episode of Not So Different, we spoke with Sonia T. Oskouei, PharmD, BCMAS, DPLA, vice president of biosimilars at Cardinal Health, to discuss the US launch of Byooviz, the first ophthalmology biosimilar in the United States, and how it's expected to impact ophthalmology care.

A survey study found that many patients with breast cancer reported receiving inadequate information regarding switching from Herceptin to a trastuzumab biosimilar, with some patients reporting that they were never told a switch occurred or what a biosimilar was.

Here are the top 5 biosimilar articles for the week of July 4, 2022.

As Alvotech announced that dosing of patients with its aflibercept biosimilar candidate has begun, Viatris announces its third recall for a batch of its insulin glargine biosimilar over missing labels.

Some of the problems with use of biologics in the cardiovascular field resemble those seen with all biologic drugs, while the authors say others are unique to the complexity of cardiovascular disease.

During its annual conference in Sitges, Spain, Medicines for Europe recommended policy reforms for strengthening European health systems, including the use of off-patent medications like biosimilar and generic drugs.

So far in 2022, the United States has taken some big steps in increasing biosimilar access and adoption throughout the nation, including 3 FDA approvals, an investigation into pharmacy benefit managers, and progress on congressional action.

In the first human study of Shanghai Henlius Biotech's pertuzumab biosimilar candidate (HLX11), investigators found similar pharmacokinetic (PK), safety, and immunogenicity profiles between the biosimilar and the reference product (Perjeta).

Here are the top 5 biosimilar articles for the week of June 27, 2022.