April 17th 2024
Julie Reed, executive director of the Biosimilars Forum, showcases how the biosimilar industry is expected to develop throughout 2024, including major policy changes and hope for continued improvement in market share for adalimumab biosimilars.
Study Documents HCPs’ Experiences of a Mandatory Switch to Inform Future Transitions
December 2nd 2023A survey explores the experiences of health care providers (HCP) in New Zealand throughout the transition process following a mandatory switch from the adalimumab originator (Humira) to a biosimilar in 2022.
Eye on Pharma: Denosumab Biosimilar Data; COA Forms New Committee; IGBA and WHO Collaborate
November 8th 2023Samsung Bioepis releases data for its denosumab biosimilar candidate; the Community Oncology Alliance (COA) forms the Drug Policy and Regulation Committee; the International Generic and Biosimilar Association (IGBA) and the World Health Organization (WHO) collaborate on a new initiative.
BioRationality: FDA Launches a New Opportunity to Remove Redundant Trials of Biosimilars
November 6th 2023The FDA introduced a plan to improve clinical trials, including a provision to possibly eliminate clinical efficacy testing for biologic products, which evidence has suggested may not be necessary, according to Sarfaraz K. Niazi, PhD.
AMCP Nexus: Panelists Share Current Scope of Biosimilar Industry
October 26th 2023Panelists at the Academy of Managed Care Pharmacy (AMCP) Nexus meeting chronicled the current state of the US biosimilar market, including current policies impacting the market, recent regulatory decisions, and the developing arguments around requirements for clinical efficacy studies.
Eye on Pharma: Another CRL for Alvotech; Cimerli’s Growing Market Share; BBCIC Awarded Grant
October 19th 2023Alvotech received a complete response letter (CRL) for its ustekinumab biosimilar; Formycon’s Cimerli, a ranibizumab biosimilar, achieved 25% market share in the United States; and the FDA awarded a researach grant to the Biologics & Biosimilars Collective Intelligence Consortium (BBCIC).
BioRationality—A DMF Route to Biosimilars: CDMOs Can Make Biosimilars Accessible and Affordable
October 16th 2023Sarfaraz K. Niazi, PhD, chronicles how drug master files (DMF) can be used in the biosimilar approval process and the role contract development and manufacturing organizations (CDMOs) can play in improving biosimilar accessibility.
Varying Biosimilar Policies Create Uneven Market Sustainability Across Nations
October 12th 2023An international comparative analysis found that the level of biosimilar market sustainability differs between countries, largely due to variances in biosimilar policies and years of experience managing a biosimilar market.
Biosimilars Check-In: BI Launches Unbranded Adalimumab; New Omalizumab Deal; CRL for Insulin Aspart
October 10th 2023Boehringer Ingelheim (BI) launches an unbranded version of its adalimumab biosimilar; Alvotech and Kashiv Biosciences partner for an omalizumab biosimilar candidate; the FDA issues a complete response letter (CRL) for Biocon’s insulin aspart biosimilar.
BioRationality: Calling on Developers to Help Address Remaining Biosimilar Issues
October 3rd 2023Sarfaraz K. Niazi, PhD, summarized the citizen petitions he's filed to the FDA as well as changes he believes are needed to propel the biosimilar industry into the future, including calling on biosimilar manufacturers to help.
Higher-Cost Therapies for ARMD Could Contribute to Heightened Medicare Costs; Biosimilars Could Help
September 24th 2023Drug maker payments to ophthalmologists were associated with the choice of higher-cost therapies for age-related macular degeneration (ARMD) that could increase Medicare costs, but biosimilars could help.
Part 3: BioRationality—FDA Webinar on Biosimilars Efficacy Testing Marks Major Step Forward
September 20th 2023In the final part of a 3-part series, Sarfaraz K. Niazi, PhD, gives his take on the FDA's recent workshop dedicated to streamlining biosimilar development and his opinion on what the industry can learn from the webinar presenters.
Part 1: FDA Workshop Highlights Global Regulatory View on Biosimilar Development
September 13th 2023An FDA workshop featuring regulators from around the world provided the regulatory perspective on how each government determines whether a biosimilar is clinically equivalent to their reference product, highlighting the science behind their development guidelines.
The Growth of Biosimilars Continues to Create Hope for Lower Drug Costs
September 7th 2023Perhaps the most significant development in the pharmaceutical industry in decades, crops of biosimilars are being approved and are ready for distribution. What lies next, in terms of legislation and the impact on pharmacists, remains to be seen.
Stelara and Enbrel Chosen for IRA Price Negotiation
August 29th 2023Stelara (ustekinumab) and Enbrel (etanercept), 2 originator medications that will face biosimilar competition within the next decade, were among the 10 preliminary drugs chosen for Medicare price negotiation under the Inflation Reduction Act (IRA).