Biosimilar Development News
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The Accreditation Council For Medical Affairs (ACMA) Develops First Ever Board-Certified Biologics & Biosimilars Specialist (BCBBS) Certification
12/9/2022
The Accreditation Council for Medical Affairs (ACMA) is launching a new Board Certification program focused on biologics and biosimilars. This is the first and only accredited board certification in the biologics and biosimilars arena.
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BIOCORP Obtains 510(k) FDA Clearance For Mallya®
12/7/2022
BIOCORP, a French company specialized in the design, development, and manufacturing of innovative medical devices, announced today that they have received 510(K) clearance from the U.S. Food & Drug Administration (FDA) to market Mallya, its smart medical device that connects insulin pens.
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Alvotech And STADA Broaden Access To Hukyndra® Adalimumab Biosimilar In Europe
12/7/2022
Alvotech (NASDAQ: ALVO) and STADA are contributing to the availability of high-quality biologic treatments in Europe by rolling out their Hukyndra high-concentration, low-volume, citrate-free formulation of adalimumab in several European countries.
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Datwyler Adds Steam Sterilization Option For Ready-To-Use Components For Injectable Drugs
12/1/2022
Datwyler, a leading provider of high-quality, system-critical elastomer components, announces the launch of Steam Sterilization for Ready-to-Use components. This service is applicable to non-coated and coated solutions like OmniFlex® stoppers for vials and NeoFlexä plungers for prefilled syringes and cartridges. As part of the company’s “Quality First” approach to designing and producing these packaging components, Datwyler will deliver RTU components in robust packaging guaranteeing a shelf life of 2 years after steam sterilization.
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Bioventure, Minapharm Pharmaceuticals And MiGenTra Sign An Exclusive Agreement For The Commercialization Of Multiple Biosimilar Candidates Of Alvotech In The Middle East And Africa
11/30/2022
Bioventure, a Dubai-based pharmaceutical company, Minapharm Pharmaceuticals, a Cairo-based pharmaceutical company, and MiGenTra GmbH, a Berlin-based pharmaceutical company, announced today the signing of an exclusive license agreement for the commercialization of multiple biosimilar candidates developed and manufactured by Alvotech, in Egypt and eighteen additional countries in Africa and the Middle East (the "Territory").
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Capstone Announces Authorization Of Biosimilar Human Insulin For IV Infusion In Canada And EU
11/29/2022
Capstone Development Services Company LLC ("Capstone") announced today that a biosimilar version of human insulin received authorization from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) and a Notice of Compliance from Health Canada.
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Biocon Biologics Completes Acquisition Of Viatris' Global Biosimilars Business
11/29/2022
Biocon Biologics Ltd., a subsidiary of Biocon Ltd. (BSE code: 532523) (NSE: BIOCON), announced today that it has successfully completed its multi-billion-dollar (USD) acquisition of the global biosimilars business of its partner Viatris Inc. (NASDAQ: VTRS).
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Amneal Launches Second Biosimilar With RELEUKO (filgrastim-ayow) In The United States
11/22/2022
Amneal Pharmaceuticals, Inc. (“Amneal” or the “Company”) today announced the commercial launch of RELEUKO® (filgrastim-ayow), a biosimilar referencing Neupogen.
- The First Biosimilar Medicine From The Partnership Between Sandoz And Butantan Institute Arrives At SUS 11/21/2022
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Professor Sarfaraz Niazi Convinces The US Senate To Vote On Removing Interchangeable Status Of Biosimilars
11/21/2022
The US is the only country with two classes of biosimilars; an interchangeable status is awarded to approved biosimilars after extensive switching and alternating testing in patients; this designation is mandated in the Biological Price Competition and Innovation Act (BPCIA), which is part of the Affordable Healthcare Act.1 This dual status has caused much harm in creating confidence in the safety of biosimilars. This news is provided by Novel351k, Inc.