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The Top 5 Biosimilar Articles for the Week of May 10
Here are the top 5 biosimilar articles for the week of May 10, 2021.
Hi, I’m Skylar Jeremias for The Center for Biosimilars®, your resource for clinical, regulatory, business, and policy news in the rapidly changing world of biosimilars.
Here are the top 5 biosimilar articles for the week of May 10, 2021.
Number 5: During a talk at the Medicines for Europe Biosimilar Medicines Conference, US and EU regulators discuss the potential for a tailored approach to bring biosimilars to market sooner with less expense and wasted effort.
Number 4: Pfizer doubles down on its pledge to fight rebates, and Organon executives discuss the growth potential of the planned Merck spinoff.
Number 3: Fighting back against a suit that alleges theft of trade secrets, Alvotech has filed suit against AbbVie alleging that key patents for its blockbuster adalimumab drug (Humira) should be invalidated partly on grounds that AbbVie did not invent the processes that were patented.
Number 2: This year marks the 15th anniversary of biosimilar availability in the European Union, and in an overview sponsored by Medicines for Europe, experts from regulatory and business venues discussed some of the major achievements and hurdles yet to be crossed.
Number 1: A deep dive into the anatomy of a biosimilar switching study reveals what it takes for a biosimilar to be approved as interchangeable in the United States.
To read all of these articles and more, visit centerforbiosimilars.com.
Boosting Health Care Sustainability: The Role of Biosimilars in Latin America
November 21st 2024Biosimilars could improve access to biologic treatments and health care sustainability in Latin America, but their adoption is hindered by misconceptions, regulatory gaps, and weak pharmacovigilance, requiring targeted education and stronger regulations.
Biosimilars Development Roundup for October 2024—Podcast Edition
November 3rd 2024On this episode of Not So Different, we discuss the GRx+Biosims conference, which included discussions on data transparency, artificial intelligence (AI), and collaboration to enhance the global supply chain for biosimilars and generic drugs, as well as the evolving requirements for biosimilar devices.
Eye on Pharma: EU Aflibercept Approvals; Biosimilars Canada Campaign; Celltrion Data
November 19th 2024The European Commission grants marketing authorization to 2 aflibercept biosimilars; Biosimilars Canada launches new campaign to provide sustainable solutions to employers; Celltrion shares positive data for 2 biosimilars.
Biosimilars Policy Roundup for September 2024—Podcast Edition
October 6th 2024On this episode of Not So Different, we discuss the FDA's approval of a new biosimilar for treating retinal conditions, which took place in September 2024 alongside other major industry developments, including ongoing legal disputes and broader trends in market dynamics and regulatory challenges.
Can Global Policies to Boost Biosimilar Adoption Work in the US?
November 17th 2024On this special episode of Not So Different honoring Global Biosimilars Week, Craig Burton, executive director of the Biosimilars Council, explores how global policies—from incentives to health equity strategies—could boost biosimilar adoption in the US.
Subcutaneous Infliximab CT-P13 Superior to Placebo as Maintenance Therapy for IBD
November 16th 2024In 2 randomized controlled trials of maintenance therapy for inflammatory bowel disease (IBD), the subcutaneous formulation of the infliximab biosimilar CT-P13 demonstrated superiority to placebo in patients with Crohn disease and ulcerative colitis.
