Pharma News
Alvotech acquires Xbrane
On 20 March 2025, Alvotech announced the acquisition of Sweden’s Xbrane Biopharma AB’s (Xbrane) R & D operations and a biosimilar candidate XB003, a biosimilar to Cimzia (certolizumab pegol).
Colombia boosts health sovereignty through public-private biotech collaboration agreement
On 27 February 2025, Colombia's Ministry of Health, the National Institute of Health, and VaxThera announced a pivotal agreement to enhance research, development, and production of biologicals and health technologies. This collaboration aims to strengthen health sovereignty, advance biotechnology, and improve emergency response capabilities.
Bio-Thera partners with Tabuk in Saudi Arabia and SteinCares in LATAM
Bio-Thera Solutions (Bio-Thera) has partnered with Tabuk Pharmaceutical Manufacturing (Tabuk) to exclusively manufacture, distribute, and market BAT2206, a biosimilar to Stelara (ustekinumab), in Saudi Arabia. Simultaneously, Bio-Thera expanded its collaboration with SteinCares, granting exclusive rights to distribute an additional biosimilar in Latin America, reinforcing its global biosimilar strategy.
Klinge-Teva and MS Pharma agreements for Eylea and Stelara biosimilars in Europe and MENA
Klinge Biopharma (Klinge) and Teva Pharmaceuticals (Teva) formed a semi-exclusive agreement for the commercialization of Formycon’s FYB203 biosimilar to Eylea (aflibercept) in Europe, while MS Pharma partners for the MENA (Middle East and North Africa) commercialization of FYB202, a biosimilar to Stelara (ustekinumab).
Biosimilars thrive as China’s biotech industry gains momentum
China is emerging as a global biotech leader, attracting significant investment and partnerships from multinational pharmaceutical companies. Its innovative therapies and biosimilars are gaining international traction, reshaping the industry despite ongoing challenges.
Greener Pharmaceuticals: WHO's call for innovative regulatory practices and eco-friendly innovations
The World Health Organization (WHO) has launched the ‘Greener Pharmaceuticals’ Regulatory Highway’ initiative to promote sustainability in the pharmaceutical sector. The initiative calls for innovative regulatory practices, sustainable manufacturing, and eco-friendly innovations to reduce the environmental impact of healthcare products.
Coherus exits the biosimilars market with sale of Udenyca to Intas Pharmaceuticals
On 3 December 2024, Coherus BioSciences announced that it will sell its Udenyca (pegfilgrastim) franchise, a biosimilar version of Amgen’s Neulasta, to India-based drugmaker Intas Pharmaceuticals.
Meitheal expands portfolio with three biosimilars through exclusive US licensing agreement
On 31 October 2024, it was announced that Chicago-based Meitheal Pharmaceuticals had expanded its biosimilars portfolio with an exclusive commercial licensing agreement with its parent company, Hong Kong King-Friend Industry Co, to market and distribute three biosimilars in the US. These include the oncology biosimilars pegfilgrastim and filgrastim, as well as fertility treatment follitropin alpha.
EMS proposes merger with Hypera to form Brazil's largest drugmaker
On 21 October 2024, Brazilian pharmaceutical giant EMS proposed a partnership with competitor Hypera Pharma, setting a course to become Brazil’s largest drug manufacturer.
Bio-Thera and Gedeon Richter partner to commercialize Stelara biosimilar BAT2206
In October 2024, China based Bio-Thera Solutions (Bio-Thera) and Hungary’s Gedeon Richter announced they have reached an exclusive commercialization and license agreement for BAT2206, a biosimilar candidate to Johnson & Johnson’s Stelara (ustekinumab).
Advances for Biocon Biologics’ Stelara and Eylea biosimilars
Biocon Biologics (Biocon) settled patent disputes with Janssen to commercialize Bmab 1200, a biosimilar of Stelara (ustekinumab), in several markets, including Europe and Canada. Additionally, Biocon received UK marketing authorization for Yesafili, its biosimilar of Eylea (aflibercept).
China’s Hasten Biopharma acquires 14 products from Celltrion
In July 2024, it was announced that China’s Hasten Biopharmaceutical has acquired the asset rights of 14 branded products across Pan-Asia countries and regions from Korea’s Celltrion.
Coherus sells adalimumab biosimilar Yusimry to HKF for US$40 million amid oncology focus
On 27 June 2024, Coherus BioSciences announced that is has divested Yusimry (aflibercept-jbvf), an adalimumab biosimilar to AbbVie’s rheumatoid arthritis therapy Humira, to Hong Kong King-Friend Industrial (HKF) in a US$40 million deal.
Biocon and Biomm forge alliance to bring semaglutide diabetes treatment to Brazil
By mid-April 2024, India-based Biocon Biologics signed an exclusive licensing and supply agreement that will allow Brazil’s Biomm SA to commercialise semaglutide, which is used to control type-2 diabetes in adults and has been repurposed for obesity management.
Klinge–MS Pharma and Teva–mAbxience biosimilars licence agreements
In May 2024, Klinge Biopharma announced an exclusive licensing and supply agreement with MS Pharma for FYB203 commercialization in the Middle East and North Africa (MENA) region. Previously, in April 2024, mAbxience and Teva Pharmaceuticals signed a strategic licensing agreement for a biosimilar candidate for oncology treatment.
Celltrion wins Peruvian public tenders for biosimilar infliximab and trastuzumab
In early May 2024, Celltrion reported that two of its biosimilar products, infliximab and trastuzumab, won the public tender in Peru, further expanding their prescription availability in Peru and solidifying their position in the broader Latin American pharmaceutical market.
Bio-Thera and SteinCares sign agreement to market two biosimilars in LATAM
Bio-Thera Solutions (Bio-Thera) announced in March 2024 a licensing agreement with SteinCares to market two biosimilars in Brazil and the rest of the region.
Formycon launches biosimilar ranibizumab Ravegza in Saudi, Gedeon Richter invests
In March 2024, Formycon and MS Pharma announced that their FYB201/ranibizumab Ravegza, a biosimilar to Lucentis, has received marketing authorization from the Saudi Food and Drug Authority.
mAbxience and Biosidus sign an agreement to manufacture Agalsidase Beta
mAbxience announced in February 2024 a pivotal agreement with Biosidus to manufacture Agalsidase Beta. This joint effort is expected to have a significant impact on the lives of patients affected by Fabry disease.
Biosimilars lawsuits and settlement updates for Regeneron and Alvotech
In January 2024, Regeneron filed a lawsuit against Amgen in the federal court in Los Angeles, alleging Amgen's proposed biosimilar of Regeneron's Eylea (aflibercept) violates patent rights. Additionally, in February 2024, Iceland-based Alvotech announced the anticipated global market entry dates for AVT04, a ustekinumab biosimilar to Stelara, following its settlement with Johnson & Johnson.
The journey of Pectuna pertuzumab follow-on biological in Iran
Pertuzumab is a monoclonal antibody (mAb) that inhibits the dimerization of human epidermal growth factor receptor 2 (HER2) with other HER receptors, which prevents them from signalling in ways that promote cell growth and proliferation. It is a pivotal therapeutic in oncology, targeting the overexpressed HER2 protein, particularly in breast cancer [1].
Sandoz US acquisition of ranibizumab biosimilar from Coherus
On 22 January 2024, it was announced that in the US, Sandoz will acquire ranibizumab biosimilar Cimerli (ranibizumab) from Coherus BioSciences.
Fiocruz and Pfizer sign agreement for generic of Xeljanz
Farmanguinhos/Fiocruz, the Institute of Drug Technology in Brazil, has signed a technology transfer agreement with Pfizer Brazil for the manufacturing of tofacitinib citrate, a generic counterpart to Xeljanz.
Biocon to commercialize biosimilars in 31 European countries
Biocon Biologics has successfully integrated Viatris’ biosimilars business in 31 European countries, it was announced in late November 2023.
J&J lawsuits settled over ustekinumab biosimilars
Johnson & Johnson (J&J), the maker of Stelara (ustekinumab), settled two lawsuits, one against Amgen, and the other against Alvotech and Teva Pharmaceuticals. Both lawsuits were over proposed ustekinumab biosimilars for the treatment of autoimmune conditions. These were settled in May and June 2023, respectively.
Genfar: Eurofarma's new generic brand in Latin America
Eurofarma announced on 29 September 2023 that it completed the acquisition of Laboratorios Genfar. Genfar is a generic drug company owned by the French company Sanofi, with offices in Colombia, Ecuador, and Peru.
Phase III trial results of CinnaGen’s ocrelizumab similar biotherapeutic product
Ocrelizumab is a therapeutic monoclonal antibody (mAb) that represents a different scientific approach to treating multiple sclerosis (MS). It is a humanized anti-CD20 mAb that targets CD20 marker on B lymphocytes, a typo of immune cell that plays a key role in the disease and serves as an immunosuppressive drug. Ocrelizumab binds selectively to CD20, which is expressed on the membrane of B cells. When ocrelizumab binds to CD20 on B cells, these cells are eliminated by antibody-dependent cell-mediated cytotoxicity and, to a lesser extent, complement-dependent cytotoxicity.
Insulin biosimilars: new CRL for Biocon, new deal for Meitheal/Tonghua Dongbao
In a dynamic landscape of pharmaceutical developments, Biocon Biologics (Biocon) faces a regulatory hurdle with a complete response letter from the US Food and Drug Administration (FDA), while Meitheal Pharmaceuticals expands its reach through a strategic licensing agreement with Tonghua Dongbao Pharmaceutical.
Abbott and mAbxience partnership for biosimilars in emerging markets
Abbott and mAbxience announced on 20 September 2023 that they had entered into a strategic partnership to commercialize several biosimilars in Latin America and other emerging markets.
Fresenius Kabi and Formycon reach agreement with J&J, Alvotech and Teva expand partnership
In August 2023, Fresenius Kabi and Formycon announced that they have entered into a settlement agreement with Johnson & Johnson (J&J) concerning FYB202, a proposed ustekinumab biosimilar in the US. This followed the late July 2023 news that Alvotech and Teva Pharmaceuticals (Teva) have agreed to expand their existing strategic partnership agreement.
Cuba and China strengthen ties in biotechnology
The biotechnological cooperation between Cuba and China has been a longstanding relationship in the scientific and technological realms. For the benefit of both countries, Havana and Beijing have undertaken various collaborations in the field of biotechnology, driven by their bilateral relations and shared interest in the development of the healthcare and pharmaceutical industry.
New BioFactura-CuraTeQ partnership for ustekinumab biosimilar
CuraTeQ Biologics Private Limited, a subsidiary of India’s Aurobindo Pharma Limited, has entered into an exclusive license agreement to commercialize BFI-751, BioFactura’s proposed biosimilar to Stelara (ustekinumab).
Four drugmakers sue the US government over the Inflation Reduction Act
In July 2023, Johnson & Johnson became the fourth large drugmaker to sue the US government over drug price negotiations in the Inflation Reduction Act (IRA). They join, Merck, Bristol Myers Squibb and Astellas in claiming that price negotiations by Medicare violate the First and Fifth Amendments of the US Constitution.
Celltrion–Rani partnership for RaniPill biosimilars
Celltrion and Rani Therapeutics (Rani) have entered a partnership under which Celltrion will supply ustekinumab and adalimumab biosimilars for RaniPill products under an exclusive license and supply agreement.
Cuba strengthens biotech industry through Eurasian partnerships
Cuba is consolidating its position in the field of biotechnology thanks to cooperation with several Eurasian nations, in particular Russia and Belarus.
Biosimilars manufacturing facilities approved by EU and US
Two biological drugs manufacturing facilities for biosimilar epoetin alfa and biosimilar bevacizumab were approved in the US and Europe in May and April 2023, respectively.
Cuba and China strengthen scientific cooperation for the development of medical treatments
In recent years, Cuba and China have established agreements to develop innovative medical treatments, notably Center for Genetic Engineering and Biotechnology (Centro de Ingeniería Genética y Biotecnología, CIGB) and Center for Molecular Immunology (Centro de Inmunología Molecular, CIM), and have shared their experiences in the field of medical research.
HK inno.N–mAbxience partnership in Korea and Coherus advances in the US
In early 2023, it was announced that South Korea’s HK inno.N signed an exclusive license agreement with Spain's mAbxience to bring a denosumab biosimilar to market in South Korea. In addition, in the US, Coherus BioSciences is to acquire exclusive commercial rights to Formycon’s under-development Eylea (aflibercept) biosimilar.
Global marketing and commercialization advances for Alvotech and partners
In late 2022 and early 2023, Alvotech announced several strategic partnership advances to further their global reach as a biotech company specializing in the development and manufacture of biosimilar medicines.
New partnerships: Biocon-Yoshindo and Syna-Intas
Biocon Biologics announced on 17 October 2022 that it has entered into a strategic out-licensing agreement with Japanese pharmaceuticals company Yoshindo for commercializing two of its pipeline biosimilar assets in Japan. Following this, on 2 November 2022, Syna Therapeutics signed an exclusive license agreement with Intas to commercialize a haematology biosimilar.
