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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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Switzerland-based Sandoz has announced that the US Food and Drug Administration (FDA) has approved its biosimilar Tyruko (natalizumab-sztn), developed by Polpharma Biologics. 25 August 2023

US pharmacy benefit manager (PBM) CVS Health today revealed it has set up a wholly-owned subsidiary, named Cordavis. 24 August 2023

An Expert View from Róbert Wessman, founder and chairman of Icelandic biosimilars company Alvotech and investment fund Aztiq. 23 August 2023

Swiss pharma giant Novartis (NOVN: VX) has scheduled a meeting for September 15, 2023, to gain shareholder approval for the proposed 100% spin-off of Sandoz, its generics and biosimilars. 21 August 2023

Sandoz, the soon to be spun out biosimilars and generic business of Novartis, today released positive results from the MYLIGHT Phase III confirmatory efficacy and safety study for its biosimilar aflibercept, for patients living with wet macular degeneration – a key development in its efforts to address this area of unmet medical need. 15 August 2023

German companies Fresenius Kabi and Formycon have reached a settlement with US healthcare giant Johnson & Johnson for the USA, concerning FYB202, a proposed biosimilar to Stelara (ustekinumab). 8 August 2023

South Korea’s Samsung Bioepis and USA-based Organon have announced the interchangeable result of its Humira (adalimumab) biosimilar, SB5, based on a recently conducted Phase IV study. 3 August 2023

The end of exclusivity for AbbVie’s top-selling biologic Humira (adalimumab) has provided a key test of whether biosimilars are finally ready to deliver on their promise in the US biopharmaceutical market. 2 August 2023

Germany-based STADA Arzneimittel and Sweden’s Xbrane Biopharma are considering options, including out-licensing, for their co-developed ranibizumab biosimilar candidate in North America. 25 July 2023

The US affiliate of Israel’s Teva Pharmaceutical Industries and Icelandic firm Alvotech have agreed to expand their existing strategic partnership agreement. Teva will also acquire subordinated convertible bonds to be issued by Alvotech. 24 July 2023

At its July meeting, the European Medicines Agency’s (EMA) human medicines committee (CHMP) recommended three new biosimilars and rejected one application, as well as recommending 10 novel drugs. 21 July 2023

Sandoz, the global generic and biosimilar medicines of Swiss pharma giant Novartis, today announced an investment of around $90 million at its site in Ljubljana, Slovenia, to establish a dedicated Sandoz Biopharma Development Center by 2026. 20 July 2023

Right now, the biosimilars market is at a major inflection point, with momentum building in the US Congress for new drug pricing legislation while new biosimilars of America’s bestselling biologic medicine have come to market. 19 July 2023

South Korean biosimilars company Samsung Bioepis has now released the second edition of its Biosimilar Market Report, which explores latest market trends for all biosimilars commercially available in the USA. 12 July 2023

Indian drugmaker Biocon says that its subsidiary Biocon Biologics has completed the integration of the acquired biosimilars business in over 70 countries in emerging markets effective July 1, 2023, ahead of schedule, increasing the scale and scope of its business. 7 July 2023

South Korean contract development and manufacturing organization (CDMO) Samsung Biologics today provided an update on the deal it announced last month with US pharma major Pfizer. 4 July 2023

Pharmsynthez, one of Russia's leading drugmakers, is accelerating its expansion in the domestic market by investing more than 20 billion roubles ($223 million) in the building of one of Russia’s largest complexes for the production of active ingredients and finished dosage forms within the territory of the Vorotynsk Industrial Park in the Kaluga region. 4 July 2023

A life-changing treatment to prevent blindness in premature babies is to be routinely available on England’s National Health Service (NHS), it was revealed today. 4 July 2023

The general assembly of the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) has adopted a new topic focused on the harmonization of bioequivalence for modified-release products. 3 July 2023

With the block on biosimilar versions of AbbVie’s (NYSE: ABBV) mega blockbuster Humira (adalimumab) now removed in the USA, the weekend witnessed the launch of three copycat products in the American market. 3 July 2023

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