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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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China’s Bio-Thera Solutions has recently initiated a Phase III trial of its proposed golimumab biosimilar BAT2506 in China and Eastern Europe. Against this backdrop, BAT2506 is the first subcutaneous golimumab biosimilar. 23 June 2021

Shares of pharmaceutical companies continued their upward journey at the bourses in India, with the pharma index hitting a new high. Pharma stocks are in focus amid the ongoing COVID-19 pandemic, helping register a strong gain for companies like Aurobindo Pharma, Dr Reddy’s Laboratories and Cadila Healthcare, reports The Pharma Letter’s India correspondent. 15 June 2021

South Korean biosimilars specialist Celltrion Healthcare has presented new Phase IV data for Truxima (rituximab-abbs) at the annual meeting of the European Hematology Association (EHA). 14 June 2021

Women’s health company Theramex has entered into an agreement to register and commercialize a biosimilar version of Prolia (denosumab) from Enzene Biosciences for use in Europe, the UK, Switzerland, and Australia. 10 June 2021

Cadila Healthcare is among the leading players in India which focuses on bringing in-house developed innovative therapies for patients. Cadila Healthcare has developed a diversified COVID-19 portfolio among the Indian players through in-house development and licensing opportunities. 2 June 2021

ProBioGen and Egyptian firm Minapharm Pharmaceuticals, which owns 96.79% of Germany-based ProBioGen, have announced the incorporation of ProBioGen's subsidiary MiGenTra GmbH with headquarters in Berlin and access to a site in Cairo, which will house its principal manufacturing plant. 27 May 2021

Medicines for Europe, the trade group representing the generics and biosimilars industry in Europe, has welcomed an update to the 2020 industrial strategy published by the European Commission (EC). 18 May 2021

The US Supreme Court has denied the petition to review the Federal Circuit’s July 2020 decision concerning the Sandoz biosimilar Erelzi (etanercept-szzs) for reference medicine Enbrel (etanercept), sold by US biotech major Amgen. 18 May 2021

Recently-formed Viatris, the combination of Mylan with Pfizer’s Upjohn business, has reported results for the first quarter of 2021, which demonstrate the strength of its differentiated operating platform and commercial capabilities, its broad and diverse product portfolio and its strong R&D platform, the company said. 15 May 2021

US pharma major AbbVie has answered back in its latest row over Humira (adalimumab), the inflammatory diseases drug that it continues to sell without competition in the USA. 14 May 2021

The US Food and Drug Administration has published the guidance for industry entitled “M9 Biopharmaceutics Classification System-Based Biowaivers,” a draft of which was issued in October 2018. The guidance provides recommendations to support the biopharmaceutics classification of drug substances and the Biopharmaceutics Classification System (BCS)-based waiver of the in vivo bioequivalence study requirement for drug products. 14 May 2021

Privately-held Icelandic biopharmaceutical company Alvotech, which is seeking to become one of the leaders in the biosimilar monoclonal antibody market, has made a statement this week by filing a lawsuit against AbbVie. 12 May 2021

Last week saw Novartis’ Sandoz unit on Monday announce it is progressing the development of biosimilars to Bayer and Regeneron’s blockbuster ophthalmic drug Eylea. Also of note, the US medicine cost watchdog, the Institute for Clinical and Economic Review (ICER), issued a draft report questioning the benefit/risk of Biogen and Eisai’s Alzheimer’s disease candidate aducanumab. And Roivant Sciences entered into a $7.3 billion SPAC (special purpose acquisition company) deal with Montes Archimedes to go public. Marking an important new indication for Merck & Co’s Keytruda, the US Food and Drug Administration (FDA) approved the blockbuster drug for the first-line treatment of HER2-positive gastric cancer. 9 May 2021

Monday saw the announcement of progress for biosimilars of two important ophthalmic drugs; Bayer’s Eylea (aflibercept) and Novartis’ Lucentis (ranibizumab), which generated full-year 2020 revenues of 2.47 billion euros ($2.97 billion) and $1.93 billion, respectively. 4 May 2021

Boehringer Ingelheim as announced results from a Phase III, randomized study that concluded that switching several times from Humira (adalimumab) to Cyltezo (adalimumab-adbm) produced similar clinical outcomes in terms of pharmacokinetics, efficacy, immunogenicity, and safety in people with moderate-to-severe chronic plaque psoriasis. 24 April 2021

An ophthalmic formulation of Roche and Genentech’s Avastin (bevacizumab), under development for use in retinal indications, has fared well in a Phase III safety study. 1 April 2021

German drugmaker STADA Arzneimittel has broadened its specialty oncology portfolio by introducing its Oyavas (bevacizumab) biosimilar upon receiving a pan-European marketing authorization. 31 March 2021

Biosimilar medicines are increasingly relevant to public health as emphasised by the new Pharmaceutical Strategy for Europe. 31 March 2021

South Korea’s Samsung Bioepis says it is expanding its global footprint to Australia with the launch of Hadlima (adalimumab), a biosimilar referencing AbbVie’s (NYSE: ABBV) mega-billion drug Humira. 29 March 2021

China’s TOT Biopharm International today announced its financials and provided a review of its clinical milestones and pipeline achievements. 24 March 2021

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