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16 May 2025 Danish diabetes and weight loss juggernaut Novo Nordisk is to part ways with its chief executive Lars Fruergaard Jørgensen as the group seeks to reverse its fortunes.
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Biosimilars
Yesterday, the US Food and Drug Administration (FDA) issued a draft guidance, Postapproval Manufacturing Changes to Biosimilar and Interchangeable Biosimilar Products. 23 July 2024
Biosimilars
The US Food and Drug Administration (FDA) has approved the Biologics License Application (BLA) submitted by South Korea’s Samsung Bioepis for Epysqli (eculizumab-aagh) as a biosimilar to Soliris (eculizumab). 22 July 2024
Biosimilars
Gedeon Richter today announced that the European Medicines Agency (EMA) has accepted the company’s two marketing authorization applications (MAAs) for its proposed biosimilar to denosumab. 19 July 2024
Biosimilars
Privately-held German drugmaker Boehringer Ingelheim has inked a deal with GoodRx (Nasdaq: GDRX), in a bid to boost US penetration of its biosimilar to Humira (adalimumab). 18 July 2024
Biosimilars
The mandate to conduct routine comparative clinical efficacy studies for biosimilar medicines, compounded by duplicative regional requirements, serves as a barrier to greater medicine access for patients, said the trade group International Generic and Biosimilar Medicines Association (IGBA). 13 July 2024
Biosimilars
South Korea’s Samsung Bioepis has released its Third Quarter 2024 Biosimilar Market Report, which includes the latest Average Sales Price (ASP) information of all biosimilars and reference products available in the US market. 12 July 2024
Biosimilars
India's Zydus Lifesciences has been barred by the Delhi High Court from selling its breast cancer drug, Sigrima, a biosimilar version of Roche's pertuzumab (brand name Perjeta). 12 July 2024
Biosimilars
The US Food and Drug Administration (FDA) has approved the Biologics License Application (BLA) for Pyzchiva (ustekinumab-ttwe) submitted by South Korean firm Samsung Bioepis. 1 July 2024
Biosimilars
In the USA, the Food and Drug Administration has announced the availability of a draft guidance for industry which could smooth the path for biosimilars developers to gain interchangeable status for their products. 21 June 2024
Biosimilars
The recent US crackdown on Chinese biotech companies marks a significant shift in the global biotechnology landscape, with profound implications for competitive strategies. 18 June 2024
Biosimilars
Celltrion has announced positive Phase III data for CT-P47, a biosimilar referencing Actemra (tocilizumab). 14 June 2024
Biosimilars
South Korea’s Samsung Bioepis today presented the post-hoc analysis of the Phase III clinical study results for Epysqli (SB12), a biosimilar to AstraZeneca’s Soliris (eculizumab), at the EHA Congress. 14 June 2024
Biosimilars
Icelandic company Alvotech and Germany’s STADA Arzneimittel are strengthening their existing strategic alliance for biosimilars by extending their partnership to cover AVT03. 13 June 2024
Biosimilars
As the BIOSECURE Act progresses through the US legislative process, the US pharmaceutical industry finds itself at a crossroads. 10 June 2024
Biosimilars
Italy's Competition Authority (AGCM) is investigating four pharmaceutical companies over what it called coordination of their commercial strategies, allegedly delaying access to a biosimilar eye-disease treatment in the country. 6 June 2024
Biosimilars
As more biologics drugs lose their patent protection, the influx of biosimilars is set to expand, offering cost-effective alternatives and significantly impacting their respective markets. 5 June 2024
Biosimilars
Bio-Thera Solutions has partnered with STADA Arzneimittel for the commercialization of BAT2506, a biosimilar candidate to Simponi (golimumab). 30 May 2024
Biosimilars
The US Food and Drug Administration has approved US biotech major Amgen’s Bkemv (eculizumab-aeeb) as the first interchangeable biosimilar to Soliris (eculizumab) to treat certain rare diseases. 30 May 2024
Biosimilars
Chief Executive Officers of the world’s largest generic and biosimilar medicines companies recently met in Vienna, Austria, to provide strategic advice to the International Generic and Biosimilar Medicines Association (IGBA). 29 May 2024
Biosimilars
The European Commission (EC) has approved Omlyclo (CT-P39), an omalizumab biosimilar referencing Xolair. 24 May 2024
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Biosimilars
The US Food and Drug Administration’s (FDA biosimilar approvals reached a record 19 in 2024, with projections indicating that 2025 could surpass this milestone trend. 16 May 2025
Biosimilars
Teva Pharmaceutical Industries’ US subsidiary and Iceland-based Alvotech (Nasdaq: ALVO) today announced that the US Food and Drug Administration (FDA) has approved Selarsdi (ustekinumab-aekn) injection as interchangeable with the reference biologic Stelara (ustekinumab). 5 May 2025
Biosimilars
Swiss generics and biosimilars major Sandoz has signed a global collaboration with Shanghai Henlius Biotech to commercialize a biosimilar of leading oncology therapy, ipilimumab, the active ingredient of Bristol Myers Squibb’s blockbuster drug Yervoy. 30 April 2025
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
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