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Biotechnology
29 April 2025 Shares of US clinical-stage biotech Biohaven rose 9.6% to $21.74 yesterday, after it announced an agreement with Oberland Capital Management for an investment of up to $600 million in the company, with the first tranche of $250 million of gross proceeds to be funded at closing on or before April 30, 2025.
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Biosimilars
India’s largest biotech firm Biocon today announced that Shreehas Tambe, currently deputy chief executive of its Biocon Biologics (BBL) subsidiary, has been appointed as managing director of the company, with effect from December 5, 2022. Mr Tambe will lead BBL in realizing its goal of being a global biosimilars leader. 5 December 2022
Biosimilars
Contract development and manufacturing organization (CDMO) Capstone Development has announced that its biosimilar version of insulin has received marketing authorization in Europe and Canada. 30 November 2022
Biosimilars
Dubai-based Bioventure, Egypt’s Minapharm Pharmaceuticals and German pharma MiGenTra have agreed to commercialize multiple biosimilars developed and manufactured by Alvotech, in 19 countries in Africa and the Middle East. 29 November 2022
Biosimilars
The US Food and Drug Administration has approved the second interchangeable biosimilar insulin product to Lantus (insulin glargine), Eli Lilly’s Rezvoglar (insulin glargine-aglr). 17 November 2022
Biosimilars
Access to therapies used to treat major chronic diseases remains particularly limited in Central and Eastern Europe (CEE). Off patent medicines are often the first opportunity for patients to access the essential medicines they need, says Medicines for Europe, the trade body representing bakers of biosimilar and generic drugs. 16 November 2022
Biosimilars
As with every sector, the biopharmaceutical field has its own lingo—a world of jargon and buzz words that develop alongside industry trends and wider societal changes, some carrying significant meaning and others representing little more than the hype of marketers. 11 November 2022
Biosimilars
Following its November 2022 meeting, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended four medicines for approval, one a biosimilar, two generics and the other a coronavirus vaccine. 11 November 2022
Biosimilars
The European Commission has granted a marketing authorization for Ximluci (ranibizumab), a biosimilar candidate referencing Lucentis, developed by Germany’s STADA Arzneimittel and Sweden’s Xbrane Biopharma. 11 November 2022
Biosimilars
Four years after it was established, Syna Therapeutics has just signed an exclusive license agreement with Indian drugmaker Intas Pharmaceuticals and its wholly-owned subsidiary Accord Healthcare for the marketing worldwide of its biosimilar medicine LB-0702 to treat pathologies in the field of hematology. 2 November 2022
Biosimilars
Following USA-based JSR Life Sciences’ launch of Similis Bio in May this year as a biosimilar partner, the new unit has signed its first development and license agreement, which is with Brazilian drugmaker Blau Farmacêutica. 25 October 2022
Biosimilars
India’s largest biotech firm Biocon has entered into a strategic out-licensing agreement with Japanese drugmaker Yoshindo for the commercializing of two of its pipeline biosimilar assets, bUstekinumab and bDenosumab, in the Japanese market. 17 October 2022
Biosimilars
US biotech major Amgen, which also has a significant presence in the biosimilar medicines sector, has released the 9th edition of its Biosimilar Trends Report, which examines the current and future state of the US marketplace with biosimilars. 17 October 2022
Biosimilars
An Expert View from Mark Samuels, chief executive, British Biosimilars Association. 12 October 2022
Biosimilars
Inflation across Europe has now risen above 10%. As a result, this has increased the manufacturing costs of essential, off patent medicines, which account for 70% of those dispensed in Europe. 12 October 2022
Biosimilars
The ability of patent holders to preserve their market exclusivity, a lack of consumer understanding and other factors have held up the widespread adoption of biosimilars in the USA compared to other markets. 5 October 2022
Biosimilars
The US Department of Health and Human Services (HHS) said yesterday that it is implementing Medicare Part B payment changes for certain biosimilars, one of the first Medicare provisions of the Inflation Reduction Act to go into effect. 4 October 2022
Biosimilars
The US health care system, including patients, employers, and taxpayers, saved $373 billion in 2021 by using Food and Drug Administration-approved generic and biosimilar drugs. 1 October 2022
Biosimilars
Biosimilars are compounds that have demonstrated no clinically meaningful differences in safety, purity and potency from a reference biologic drug. As of September 2022, 38 biosimilars have been approved for use within the USA. 29 September 2022
Biosimilars
Adding to recent market authorizations in the European Union, Japan and the UK, South Korea-based Celltrion Healthcare says its biosimilar of a Roche (ROG: SIX) cancer drug has now gained approval in the USA, sending the firm’s share up 2.7% to 171,100 won. 29 September 2022
Biosimilars
Increasing access to capital has resulted in a surge of Indian biopharmaceutical companies focusing on research and development. A think-tank has advised the government that it is imperative to streamline regulatory approval procedures for the biotechnology industry and eliminate redundant steps so as to expedite the approval process, reports The Pharma Letter’s India correspondent. 28 September 2022
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Biosimilars
South Korea’s Samsung Bioepis today released its Second Quarter 2025 Biosimilar Market Report, which provides the second quarter 2025 Average Sales Price (ASP) and Wholesale Acquisition Cost (WAC) of the commercially available biosimilars in the USA, as well as the price and market share trends since each biosimilar’s launch. 24 April 2025
Biosimilars
Physician attitudes toward patient choice between the use of biologics and biosimilars vary widely across global markets, revealing deep-rooted cultural and systemic differences. 22 April 2025
Biosimilars
Indian drugmaker Biocon subsidiary Biocon Biologics has announced a settlement and license agreement with the USA’s Regeneron that clears the way to commercialize Yesafili (aflibercept-jbvf), an interchangeable biosimilar aflibercept, in the USA. 17 April 2025
Biosimilars
China’s Chime Biologics has formed a strategic partnership with European biosimilars specialist Polpharma Biologics to support the end-to-end development and manufacture of a biosimilar product targeting the global market. 16 April 2025
Biosimilars
Innovent Biologics has recently received approval for Sycume (teprotumumab biosimilar) to treat thyroid eye disease (TED) in China, making it the country’s first insulin-like growth factor 1 receptor (IGF-1R) monoclonal antibody cleared for TED by the National Medical Products Administration (NMPA). 16 April 2025
Biosimilars
The US Food and Drug Administration (FDA) has designated Yuflyma (adalimumab-aaty) as an interchangeable biosimilar to AbbVie’s mega blockbuster drug Humira (adalimumab), to treat eight conditions, including Crohn's disease and ulcerative colitis. 15 April 2025
Biosimilars
Shares of California-based Coherus BioSciences (Nasdaq: CHRS) rose more than 5% to $0.88 in pre-market activity today as it completed a transformative transaction. 14 April 2025
Biosimilars
Swiss generic and biosimilar medicines firm Sandoz today announced it has filed an antitrust lawsuit in the USA against Amgen for extending and entrenching the dominant market position of its blockbuster medicine, Enbrel (etanercept), first approved by the US Food and Drug Administration (FDA) in 1998. 14 April 2025
Biosimilars
South Korea’s Samsung Bioepis presented data, including the budget impact analysis on ustekinumab biosimilars’ cost savings in Germany, the UK and Sweden at the 8th International Meeting on Intestinal Diseases in conjunction with the Annual Congress of the Korean Association for the Study of Intestinal Diseases (IMKASID 2025) held in Seoul, Korea. 10 April 2025
Biosimilars
Israel-based Teva Pharmaceuticals industries today revealed two important updates reflecting its commitment to expanding access to both biosimilars and innovative medicines. 7 April 2025
Biosimilars
An Expert View from Dr Elena Wolff-Holz, global head of clinical development at Biocon Biologics, the biosimilar subsidiary of Biocon. 7 April 2025
Biosimilars
The European Medicines Agency (EMA) announced it is exploring improvements to the development and evaluation of biosimilar medicines, while upholding strict European Union (EU) safety standards. 2 April 2025
Biosimilars
China's Bio-Thera Solutions has entered into an exclusive commercialization agreement with India's Dr Reddy's Laboratories for two proposed biosimilars referencing Stelara (ustekinumab) and Simponi (golimumab). 1 April 2025
Biosimilars
South Korea’s Celltrion has announced the US launch of Steqeyma (ustekinumab-stba), a biosimilar to Stelara (ustekinumab), following approval by the US Food and Drug Administration (FDA) in December 2024. 13 March 2025
Biosimilars
US pharma major Bristol Myers Squibb has announced positive data from the pivotal Phase III POETYK PsA-2 trial evaluating the efficacy and safety of Sotyktu (deucravacitinib) in adults with active psoriatic arthritis (PsA). 10 March 2025
Biosimilars
On Friday, the US Food and Drug Administration (FDA) approved as the first interchangeable biosimilar to Swiss pharma giant Roche's
anti-IgE monoclonal antibody Xolair (omalizumab). 8 March 2025
Biosimilars
Swiss generics and biosimilars giant Sandoz today announced financial results for the full year 2024, showing that sales were $10.4 billion, up by 9% in constant currencies (+7% in $). 5 March 2025
Biosimilars
South Korea-based Celltrion today announced that the US Food and Drug Administration (FDA) has approved Stoboclo and Osenvelt (CT-P41, denosumab-bmwo), biosimilars referencing Amgen’s Prolia and Xgeva brands respectively for all indications of the reference products. 4 March 2025
Biosimilars
Johnson & Johnson has taken legal action against Samsung Bioepis, accusing the South Korean biotech of violating a settlement agreement by authorizing a third party to market a private-label biosimilar version of Stelara (ustekinumab). 27 February 2025
Biosimilars
South Korean firm Celltrion announced that the European Commission (EC) has granted marketing authorization for Avtozma (CT-P47), a biosimilar referencing RoActemra (tocilizumab), which is marketed by Swiss pharma giant Roche. 25 February 2025
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