The European Commission has granted marketing authorization to Samsung Bioepis' biosimilar referencing Soliris (eculizumab). The product, dubbed Epysqli, is the first hematology biosimilar from Samsung Bioepis to be approved in the European Union.

In his latest column, Sarfaraz K. Niazi, PhD, went over some best practices for implementing innovative solutions for the purposes of streamlining biosimilar development.

Amgen has settled with Johnson & Johnson (J&J) over the former’s ustekinumab biosimilar referencing Stelara, delaying the projected launch of the candidate from late 2023 to January 2025.

On this episode of Not So Different, Tasmina Hydery and Brian Biehn from AmerisourceBergen discussed results from a recent survey, that were also presented at Asembia 2023, diving into the payer perspective on biosimilars and current pricing trends across the US biosimilar industry.

Biosimilar market penetration has been slower than that of generics but the market share of biosimilars has grown over time, according to the authors of a study on biosimilar use in the European Union (EU).

A group of panelists at Asembia 2023 shared the bigger role that pharmacists, payers, and providers can play in growing biosimilar acceptance and championing policy changes that boost biosimilar utilization.

Celltrion Healthcare announced that the FDA has approved Yuflyma (adalimumab-aaty) as the ninth biosimilar referencing Humira (adalimumab).

Findings from a recent study emphasize the need for improvement and changes regarding follow-on biologics and biosimilars in the global biosimilar market.

As Celltrion Healthcare announces the launch of the biobetter version of Remsima (Remsima SC) in Brazil, the company shared the phase 3 plan for its ocrelizumab biosimilar to treat multiple sclerosis (MS).

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.

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.

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.

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.

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.