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Merck KGaA Seeks to Exit the Biosimilar Business
As a result of increasing competition, a smaller player (in the biosimilar field) is seeking to sell its nascent biosimilar business.
As a result of increasing competition, a smaller player (in the biosimilar field) is seeking to sell its nascent biosimilar business. Merck KGaA (which operates in the US as EMD Serono and is not associated with Merck & Company) has engaged the services of the investment banker JP Morgan Chase to seek potential buyers for its biosimilar unit.
Merck KGaA has decided to fortify its pipeline efforts instead on multiple sclerosis, where it has a strong marketing position with its product Rebif®, and in several cancer therapeutic approaches. The company’s only late-stage biosimilar is adalimumab (MSB11022), which is currently involved in a phase 3 trial with 400 patients that is supposed to be completed by September 2017. The primary endpoint results are slated to be available, however, in December 2016.
According to the announcement, the company’s biosimilars business could be valued at as much as $1 billion, not only based on its adalimumab agent but several undisclosed early-stage biosimilars. However, Merck may not make a big splash with its key product, as Amgen’s adalimumab has already been approved, and it may be one of several biosimilar versions to hit the market in the next few years, pending clearance of patent litigation.
In other news…Active biosimilar player Celltrion, from South Korea, has announced its submission of an application to the European Medicines Agency to license its version of Herceptin®. Interestingly, although it is approved for use in South Korea under the brand name Herzuma®, this biosimilar only commenced phase 1 trials in the US in September for eventual application to the Food and Drug Administration. No timetable has been announced for US submission.
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.
