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Korean company Samsung Biologics has signed a production agreement with an unidentified large US pharma corporation worth more than $1.06 billion. 3 July 2024

The proposed US BIOSECURE Act was this week left out of the House Rules Committee’s final list of amendments to be voted on for inclusion in the NDAA, an agreement that specifies the budget and spending for the US Department of Defense. 15 June 2024

South Korea-based Celltrion’s US subsidiary says it has now launched an 80mg dose of Yuflyma (adalimumab-aaty), a high-concentration (100mg/mL) and citrate-free formulation of AbbVie’s Humira biosimilar, in the USA. 22 January 2024

Canadian trade group Biosimilars Canada has announced a new switching policy for the province of Prince Edward Island (PEI). 13 October 2023

Biosimilars

BRIEF—US biosimilars market report

South Korea’s Samsung Bioepis today released the Fourth Quarter 2023 Biosimilar Market Report which explores latest market trends for all biosimilars commercially available in the USA. 10 October 2023

6 October 2023

US pharma giant Pfizer today announced that the US Food and Drug Administration (FDA) has designated Abrilada (adalimumab-afzb) as an interchangeable biosimilar to AbbVie’s mega-blockbuster Humira (adalimumab). 5 October 2023

South Korea’s Samsung Bioepis is considering acquiring the biosimilar business unit of US biotech Biogen for around 1 trillion won ($775.3 million) to improve its presence in the US market, according to local media reports on Wednesday. 3 August 2023

Japanese drugmaker Chugai, Roche (the majority owner of Chugai), and Roche unit Genentech have filed a patent infringement lawsuit in the US District Court for the District of Massachusetts. 14 July 2023

UK biopharma Arecor Therapeutics has entered into an agreement with an unnamed ‘leading biopharmaceutical company’ to support the ongoing development of a biosimilar product. 5 July 2023

The US Food and Drug Administration (FDA) has approved German family-owned drug major Boehringer Ingelheim’s Cyltezo Pen, a new autoinjector option for Cyltezo (adalimumab-adbm), an FDA-approved Interchangeable biosimilar to AbbVie’s Humira (adalimumab). 22 May 2023

Indian firm Biocon Biologics’ integrated, multi-product, monoclonal antibodies (MAbs) drug substance manufacturing facility (B3) at Biocon Park, Bengaluru, has received a certificate of Good Manufacturing Practices (GMP) Compliance for an additional product, biosimilar bevacizumab, from the representative European inspection authority, Health Products Regulatory Authority (HPRA), Ireland. 28 April 2023

Israeli generics giant Teva Pharmaceutical Industries announced that the US Food and Drug Administration (FDA) has issued a complete response letter (CRL) to its partner Alvotech for the Biologics License Application (BLA) for AVT02, a high-concentration biosimilar candidate for AbbVie’s Humira (adalimumab). 14 April 2023

The Canadian territory of Yukon has become the 10th jurisdiction in Canada to announce a biosimilars switching policy. 31 March 2023

Generics and biosimiliars company Sandoz has signed a memorandum of understanding to build a new biologics production plant in Slovenia, with an expected investment of over $400 million. 9 March 2023

The US Food and Drug Administration yesterday published a funding opportunity announcement (FOA) for fiscal year 2023 to support research projects that enhance biosimilar and interchangeable biological product development and regulatory science. 17 February 2023

Icelandic firm Alvotech and Germany’s STADA are launching their Humira (adalimumab) biosimilar Hukyndra (adalimumab) in several European countries. 7 December 2022

Industry analyst PharmaVentures have releases a new white paper examining the market landscape and key success factors for biosimilars. 14 November 2022

Adding to the roll out of their biosimilar to AbbVie’s mega blockbuster drug Humira (adalimumab), Icelandic firm Alvotech and German partner STADA Arzneimittel today announced the launch of Hukyndra in Switzerland. 22 September 2022

Biocon subsidiary Biocon Biologics has received a European Union certificate of Good Manufacturing Practice (cGMP) for its Bengaluru, India-based facility. 5 July 2022

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As the World Health Organization (WHO) considers amending guidelines for evaluating biosimilars so that Phase III clinical trials can be waived for biosimilar products, India may take a greater interest in developing biosimilars. 14 March 2022

Samsung Bioepis and the Canadian subsidiary of US biotech major Biogen today announced that Health Canada has approved Byooviz – a biosimilar referencing Lucentis (ranibizumab). 10 March 2022

Privately-held Icelandic biosimilars developer Alvotech Holdings says it has executed a US settlement agreement with AbbVie that grants Alvotech non-exclusive rights to market AVT02 (100mg/mL), its high-concentration, citrate-free biosimilar candidate for Humira (adalimumab) in the USA 9 March 2022

The US Food and Drug Administration yesterday published a funding opportunity announcement (FOA) to support research projects that enhance biosimilar and interchangeable biological product development and regulatory science. 8 March 2022

Biocon subsidiary Biocon Biologics has agreed to buy the biosimilars unit of Viatris for $3.3 billion. 28 February 2022

The US Food and Drug Administration (FDA) has accepted for review the Prior Approval Supplement (PAS) to the Biologics License Application (BLA) submitted by pharma giant Pfizer for Abrilada (adalimumab-afzb) as an interchangeable biosimilar to Humira (adalimumab). 26 February 2022

South Korea’s Celltrion Healthcare announced new data sets on the SC formulation of infliximab, Remsima (CT-P13) in IBD, at the European Crohn’s and Colitis Organization (ECCO) virtual congress 2022. 21 February 2022

Even as US President Joe Biden called for the US Senate to approve his Build Back Better legislation to reduce the costs of prescription drugs provided through Medicare and cap out-of-pocket drug costs for seniors, including insulin at $35 per month, Indian drug manufacturers are expecting an even stronger focus on generics and biosimilars, reports The Pharma Letter’s India correspondent. 17 February 2022

US biotech major Biogen and Swedish firm Xbrane Biopharma have entered into a commercialization and license agreement to develop, manufacture, and commercialize Xcimzane, a pre-clinical monoclonal antibody that is a proposed biosimilar referencing Cimzia (certolizumab pegol). 10 February 2022

Indian drugmaker Lupin Limited today revealed it has entered into a license, supply and technology sharing agreement with Axantia Holding for the distribution of its Pegfilgrastim, a biosimilar of Amgen’s Neulasta (pegfilgrastim). 1 February 2022

South Korea-based Samsung BioLogics has reached an agreement for the buyout of Biogen's (Nasdaq: BIIB) stake in their biosimilars joint venture, Samsung Bioepis, for $2.3 billion. 28 January 2022

Hailing the benefits of 15 years of biosimilar prescribing in Europe, The Biosimilar Medicines Group has called on the European Medicines Agency to take stronger action to widen access to this type of medicine. 25 January 2022

The ongoing review of the European pharmaceutical legislation framework is a major opportunity to update the regulatory system in the European Union, says Medicines for Europe, which represents the generics and biosimilars drugmakers. 24 January 2022

Biosimilars focussed Icelandic company Alvotech Holdings and Oaktree Acquisition Corp. II (Oaktree II), a special purpose acquisition company sponsored by an affiliate of Oaktree Capital Management, today announced $21 million in additional commitments for a private placement (PIPE) of Oaktree II common stock in connection with their proposed business combination. 19 January 2022

Biosimilar drugs could drive down prices for expensive medicines used to treat illnesses such as cancer and rheumatoid arthritis, with savings estimated to be $38.4 billion or 5.9% of projected total US spending on biologics from 2021 to 2025, according to a new RAND Corporation study. 11 January 2022

Effective January 3, German drugmaker STADA Arzneimittel is strengthening its biosimilars capabilities with the appointment of Erin Federman as global commercial head, Biosimilars and vice president. 5 January 2022

USA-based Viatris announced that it is pleased with decisions issued that affirm the US Patent and Trademark Appeal Board's prior rulings that found the challenged claims of Sanofi's Lantus (insulin glargine) SoloSTAR device patents, US Patent Nos 9,603,044, 8,992,486, 9,526,844, 9,604,008, and 8,679,069, unpatentable. 30 December 2021

Women’s health specialist Theramex has entered into an agreement with Enzene Biosciences to develop, register and commercialise a biosimilar of Roche’s RoActemra (tocilizumab). 24 December 2021

With the recent launch of the Avastin (bevacizumab) biosimilar in China, Henlius, the biotech arm of Fosun Pharma, now has four biosimilars under its belt. However, the Shanghai-based firm is eager to shake off the image of a biosimilars supplier. 22 December 2021

The Food and Drug Administration yesterday approved the second biosimilar insulin product, Eli Lilly’s Rezvoglar (insulin glargine-aglr). 21 December 2021

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