Samsung Bioepis' Eculizumab Biosimilar Approved in EuropeMay 31st 2023
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.
What AmerisourceBergen's Report Reveals About Payers, Biosimilar Pricing TrendsMay 28th 2023
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.
Study: Biosimilar Market Share Has Increased Over Time in All European MarketsMay 27th 2023
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).
Biosimilar Acceptance Takes Time but Policy Intervention Is Needed, Panelists SayMay 25th 2023
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 Launches Biobetter in Brazil, Shares Phase 3 Plan for MS BiosimilarMay 22nd 2023
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).
Stability of Biosimilar Insulin Aspart Using an Insulin Pump Was Comparable With NovoLog, Study FindsMay 20th 2023
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.
Biosimilars Business News Recap: A New Partnership; Celltrion Wins TendersMay 17th 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.
Fylnetra Launches in the United StatesMay 16th 2023
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.
Biorationality: Advice for the FDA, Biosimilar Developers on Reducing the Cost of Clinical TestingMay 15th 2023
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.
Dr Vibeke Strand: The Current State of Immunology Biosimilars and the Promise of Future SavingsMay 14th 2023
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.
Tocilizumab Biosimilar LZM008 Demonstrates PK Equivalence in Healthy ParticipantsMay 13th 2023
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.
Julie Reed: The Status Quo for Biosimilars Needs to Change to Maintain the IndustryMay 11th 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.
Samsung Bioepis Report Correlates Biosimilar Pricing Changes With Market AdoptionMay 10th 2023
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.
Dr Colby Evans: The Managed Care Perspective on Biosimilars in ImmunologyMay 9th 2023
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.
RWE: Rituximab Biosimilar GP2013 Effective in Patients With RA After Switching From OriginatorMay 8th 2023
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.
Long-term Phase 3 Results Show Similar Efficacy, Cardiac Safety of SB3 vs HerceptinMay 6th 2023
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.
Asembia: Payers More Likely to Prefer Multiple Biosimilars for the Same Reference ProductMay 4th 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.
Despite Concerns Over Extrapolation, Bevacizumab Biosimilars Are Widely Used in mCRCMay 3rd 2023
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.
Samsung Bioepis Shares 1-Year Phase 3 Results for Eylea BiosimilarMay 2nd 2023
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).
BioRationality: FDA Advice to Biosimilar Developers on Using PD Markers, Avoid Clinical Efficacy TestingMay 1st 2023
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.
Biosimilars Rheumatology Roundup for April 2023—Podcast EditionApril 30th 2023
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.