News

A phase 1 study compared pharmacokinetics (PK), pharmacodynamics (PD), safety, and immunogenicity between SB12, a proposed eculizumab biosimilar, and EU and US reference products (Soliris) in healthy adults.

Here are the top 5 biosimilar articles for the week of August 8, 2022.

Sarfaraz K. Niazi, PhD, a professor, entrepreneur, and biosimilar advocate, took aim at criticisms of the Inflation Reduction Act to 2022 that was passed in the Senate and critiques the argument that the bill should be considered a “price control” measure.

Study authors found the pair of biosimilars performed as well as others that have been evaluated in inflammatory bowel disease (IBD), but concluded that the adalimumab biosimilars were less effective in IBD than an infliximab biosimilar previously studied.

A systematic review found that patients who were switched from one biosimilar to another did not experience a change in clinical outcomes or an increase in adverse events.

While efforts to cap monthly insulin costs for Medicare patients at $35 survived a budget reconciliation bill in the Senate, Republicans blocked the measure from extending to the private sector.

On this episode of Not So Different, we recap some of the biggest biosimilars news that happened over the past month, including updates on clinical trials for oncology biosimilars as well as a survey on whether patients were given adequate information prior to switching a biosimilar.

In an interview with The Center for Biosimilars®, Hyoung Ki Kim, vice chairman and CEO of Celltrion Healthcare, breaks down the benefits of biobetters, how they differ from biosimilars, and how they could alter the future landscape of the biologics industry.

Here are the top 5 biosimilar articles for the week of August 1, 2022.

In a statement, Fresenius Kabi officials said the company is rapidly expanding its portfolio in autoimmune and oncology conditions.

Another ranibizumab biosimilar, Byooviz, is approved, but Coherus’ product is the first deemed interchangeable, which involves additional FDA requirements that allow substitution without intervention of the prescribing clinician.

Vizient’s Pharmacy Market Outlook report offers predictions on how the emergence of adalimumab biosimilars in 2023 will affect the biosimilar industry and what actions should be taken in advance to ensure biosimilar adoption.

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.