News

Fran Gregory, PharmD, vice president of emerging therapies at Cardinal Health, discusses how the use of biosimilars in other countries strengthens the acceptance and approval of these products in the United States.

Authors of a new in vitro study said Sanofi’s biosimilar SAR341402, approved in June 2020 by the European Medicines Agency for use in insulin pumps, had similar stability compared with the originator under stress conditions in their experiments.

Here are the top 5 biosimilar articles for the week of May 15, 2023.

As Sandoz and Just-Evotec Biologics announce a new partnership, Celltrion secures tender wins in Italy and Belgium, and Alvotech begins testing its golimumab biosimilar in patients with rheumatoid arthritis.

Amneal Pharmaceuticals has announced the launch of its pegfilgrastim biosimilar, Fylnetra (pegfilgrastim-pbbk), for the treatment and prevention of febrile neutropenia, making it the sixth biosimilar referencing Neulasta to enter the US market.

Although the FDA has consistently edited its testing guidelines for biosimilar developers over the years, clinical testing is still very expensive and time-consuming. Sarfaraz K. Niazi, PhD, offers the FDA and companies a plan of action for reducing clinical testing expenses for biosimilar products.

In light of 2 blockbuster originators, namely Humira (adalimumab) and Stelara (ustekinumab), losing market exclusivity in 2023, 3 doctors penned supplement in The American Journal of Managed Care®. On this episode, Vibeke Strand, MD, one of the co-authors, explored how health systems can take charge and boost biosimilar adoption.

A phase 1 clinical trial in China comparing the tocilizumab biosimilar candidate LZM008 to the reference product (Actemra) found pharmacokinetic (PK) parameters within the bioequivalence margins and similar immunogenicity and safety in healthy participants.

Here are the top 5 biosimilar articles for the week of May 8, 2023.

The 2023 Asembia Specialty Pharmacy Summit featured Juliana (Julie) Reed, executive director of the Biosimilars Forum, who spoke on the challenges still facing the biosimilars industry and how they may impact the success of adalimumab biosimilars in the United States.

In the first edition of Samsung Bioepis’ Biosimilar Market Report, the company outlined the current state of the US biosimilars market and how increasing adoption has had an impact on pricing changes for biosimilars and their reference products.

Colby Evans, MD, a dermatologist and co-author of an American Journal of Managed Care® supplement “Biosimilars for Immune-Mediated Inflammatory Diseases: 2022 Update" shares the managed care perspective on using biosimilars to treat inflammatory conditions.

In a study including 2 years of real-world evidence (RWE), patients with rheumatoid arthritis (RA) who were switched from originator rituximab (Rituxan) to GP2013, a rituximab biosimilar, experienced positive results and maintained clinical outcomes.

Andre Harvin, PharmD, executive director of pharmacy and oncology services at Cone Health, explains how oncologists can work with other stakeholders to expand access to biosimilars and how patients can work with providers and biosimilar manufacturers to address financial challenges.

The authors of what they say is the largest and longest follow-up study comparing the trastuzumab biosimilar SB3 to the reference product (Herceptin) in HER2-positive breast cancer found “no clinically meaningful difference” between the biosimilar and the reference product.

Here are the top 5 biosimilar articles for the week of May 1, 2023.

In a panel at the 2023 Asembia Specialty Pharmacy Summit, speakers presented on the payer perspective regarding biosimilars, including that they feel comfortable preferring multiple biosimilars for the same reference product and are looking for interchangeability designations.

A review article investigating the use of bevacizumab biosimilars found that despite lingering concerns about their usage for extrapolated indications, bevacizumab biosimilars are regularly used in metastatic colorectal cancer (mCRC) even though clinical tests only evaluate them in patients with lung cancer.

At the 2023 Association for Research in Vision and Ophthalmology Annual Meeting, Samsung Bioepis shared comparable safety, efficacy, and immunogenicity data through 1 year between its aflibercept biosimilar (SB15) and the originator (Eylea).

Sarfaraz K. Niazi, PhD, dives into how pharmacodynamic (PD) markers may be better than clinical efficacy testing for predicting whether a biosimilar is equally as safe and effective as its reference product, in his latest column.

On this episode of Not So Different, we recap some of the main news in April regarding biosimilars used to treat rheumatic conditions, including some progressions and some setbacks as well as research on nonmedical switching from originators to biosimilars.

In April, biosimilars to treat rheumatic conditions had some progress, as well as some setbacks, and research showed that switching from originators to biosimilars is safe and effective but warned about the nocebo effect.

Biosimilar ranibizumab showed similar efficacy and safety in a recent study of the eyes of Indian patients with neovascular age-related macular degeneration.

Here are the top 5 biosimilar articles for the week of April 24, 2023.

Nonmedical switches from Humira (reference adalimumab) to a biosimilar or an adalimumab biosimilar to another biosimilar resulted in nocebo effect responses, suggesting that more communication between providers and patients is needed, according to a real-world analysis.

Over the past week, Vegzelma, a bevacizumab biosimilar, launched in the United States; 2 biologics license applications (BLAs) for biosimilars were accepted for review by the FDA; and China’s regulatory agency approved a denosumab biosimilar.

Two US senators introduced a bipartisan bill to extend the $35 out-of-pocket cap for insulin products, established by the Inflation Reduction Act for Medicare plans, to the commercial sector.

A recent systematic review looked at the impact of different prices for infliximab in inflammatory bowel disease and the willingness-to-pay threshold around the world.

Andre Harvin, PharmD, executive director of pharmacy and oncology services at Cone Health, expressed staunch belief that biosimilars referencing Neulasta Onpro, the on-body injector version of reference pegfilgrastim, are one of the most exciting things coming to the supportive cancer care space.

A long-term follow-up of a phase 3 study comparing ranibizumab biosimilar SB11 to the reference product (Lucentis) in neovascular age-related macular degeneration (nAMD) found the similarity in efficacy end points reported early on was maintained through 52 weeks.