February 6th 2025
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended 3 biosimilars and new indications for reference biologics, moving them closer to final European approval and expanding patient access.
January 15th 2025
Review Highlights Most Popular European Policies to Boost Biosimilar Uptake
April 3rd 2024Although tender systems are a common strategy to encourage biosimilar utilization across Europe, policies like automatic substitution are rarely utilized, according to a systematic review of European policies and biosimilar uptake.
Study: More Biosimilar Competition Is Not Lowering Patient OOP Costs
March 29th 2024Despite more biosimilars entering the market and generating significant savings for payers and health care systems, these savings are not resulting in lower out-of-pocket (OOP) costs for patients, according to a recent study.
Webinar Addresses Solutions to Improve Adalimumab Biosimilar Uptake
March 18th 2024Government policies, including those related to prescribing incentives and interchangeability, need to be reworked to encourage biosimilar adoption and create meaningful savings for health systems, according to speakers at a recent webinar.
BioRationality: MHRA's Procedure Enables Automatic Registration of Biosimilars Approved Elsewhere
March 18th 2024Sarfaraz K. Niazi, PhD, explains how the new international recognition procedure under the Medicines and Healthcare Products Regulatory Agency (MHRA) could expand biosimilar access within the United Kingdom, in his latest column.
BioRationality: EMA Announces Readiness to Waive Comparative Efficacy Studies of Biosimilars
March 4th 2024Sarfaraz K. Niazi, PhD, takes a look at the European Medicines Agency's (EMA) announcement that it will investigate whether comparative efficacy tests should be needed for a biosimilar to receive regulatory approval.
Cardinal Health Report Showcases Biosimilar Growth, Provider and Payer Evolution, and More
February 29th 2024In its annual biosimilars report, Cardinal Health provided updates on how provider acceptance growth, evolving payer dynamics, and the growing pipeline for biosimilars will shape the biosimilar landscape over the next 5 years.
The Underlying Economics of Unbranded Biologics
February 26th 2024Unbranded biologics primarily serve to uphold inflated list prices, typically prompted by loss of exclusivity, aiming to safeguard market share and counter biosimilar competition, although forthcoming legislative changes targeting high drug costs could lessen their significance moving forward.
FDA Approves 10th Adalimumab Biosimilar, Simlandi
February 24th 2024After receiving 3 complete response letters, Alvotech has officially received US approval for its adalimumab biosimilar (AVT02; Simlandi), making it the first approval for the company, the 10th biosimilar to reference Humira, and the third interchangeable adalimumab biosimilar.
Eye on Pharma: VA Picks Hadlima; Biocon, Sandoz Partnership; A Stelara Settlement Abroad
February 21st 2024The US Department of Veterans Affairs (VA) has chosen to replace Humira (adalimumab) with Organon’s biosimilar version on its national formulary; Biocon Biologics and Sandoz announce a new partnership in Australia for 2 biosimilars; Alvotech settles with Johnson & Johnson over its biosimilar to Stelara (ustekinumab) for the European and Canadian markets.
Biosimilar Substitution Within OCM Could Result in Lower Total Cost of Care
February 16th 2024Researchers found that the total cost of care per oncology episode was significantly lowered when biosimilar substitution was implemented in Medicare’s Oncology Care Model (OCM), suggesting that biosimilar uptake can serve as a critical tool to mitigate risk and improve financial performance for providers.
Report: Policy Changes Needed to Ensure Long-Term Market Stability for Biosimilars
February 15th 2024The report stresses the need to tackle issues like misaligned rebates, slow uptake, and market viability to sustain biosimilars' benefits for health care, highlighting challenges in reimbursement and suggesting policy changes for a stable environment.
Eye on Pharma: Celltrion Biosimilars Win Tenders; Oral Ustekinumab Device Passes Phase 1 Trial
February 12th 2024Celltrion announced that 3 of its oncology biosimilar products have won tender contracts in France and Italy, and an experimental oral delivery device utilizing an ustekinumab biosimilar was successful in a phase 1 study.
The Hatch-Waxman Act Turns 40: The Law That Made Biosimilars Possible
February 8th 2024To mark the 40th anniversary of the Hatch-Waxman Act, the Association for Accessible Medicines published a white paper outlining the benefits and challenges associated with the landmark policy as well as solutions to ensure a stable pharmaceutical industry for the future.
Biosimilar Adoption Policy Proves Successful After 8 Years in a UK Tertiary Hospital
January 28th 2024During a 6-year follow-up period, a UK tertiary hospital observed greater biosimilar adoption than the English average after it implemented a new policy that prioritizes best-value biologics, including biosimilars, for new-start patients and those already treated with originators.
Eye on Pharma: Eylea Biosimilar Violation; New FDA Labeling Guidance; Alvotech Reinspection
January 25th 2024A Korean health agency issued Samsung Bioepis an administrative penalty related to its biosimilar referencing Eylea (aflibercept); the FDA updates its labeling recommendations for interchangeable biosimilars; Alvotech receives another Form 483 after the FDA reinspected its Iceland-based manufacturing facility.
BioRationality: It Takes 4 to Tango—How US Entities Can Make Biosimilars Accessible
January 22nd 2024The FDA, Congress, biologic developers, and associations dedicated to evaluating the US biopharmaceutical space will need to work together to overcome challenges to biosimilar accessibility, says Sarfaraz K. Niazi, PhD, in his new column.
FDA Approves First Biosimilar for Neulasta Onpro
January 15th 2024The FDA has approved Coherus Biosciences’ on-body injector version of Udenyca (pegfilgrastim-cbqv), making it the first biosimilar to reference Neulasta Onpro, the pegfilgrastim product that holds the majority of the pegfilgrastim market share.
IQVIA Report Flags Challenges With Biosimilar Access, Savings Throughout Europe
January 10th 2024IQVIA’s report on the impact biosimilar competition has had on Europe’s health care space identified ongoing challenges with biosimilar access and generating savings, calling for more policies focusing on fostering a sustainable market for years to come.
Q&A: Dr Kimberly Maxfield Explains How BsUFA III Will Advance the US Biosimilar Industry
December 20th 2023At AMCP Nexus, Kimberly Maxfield, PhD, pharmacologist at the FDA, delved into how the third reauthorization of the Biosimilar User Fee Act (BsUFA III) will shape the American biosimilar market and improve development efficiency over the next few years.
BioRationality: In FDA We Trust—A Commentary on FDA Efforts to Educate Biosimilar Stakeholders
December 18th 2023Sarfaraz K. Niazi, PhD, offers his perspective on FDA biosimilar education efforts and the role these efforts and stakeholder perspectives play in uplifting—or undermining—biosimilar adoption.