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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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Indian drugmaker Cadila Healthcare posted a net profit of 1.86 billion rupees ($29.7 million), for the fiscal third-quarter ended December 31, 2013, up 82% from the corresponding period last year. The company’s shares rose nearly 6% to 904.00 rupees on the news. 7 February 2014

In advance of today's US Federal Trade Commission workshop on follow-on biologics, or biosimilars, health advocacy organizations from across the country jointly submitted a letter to FTC Commissioner Edith Ramirez, urging her to give patient safety and consumer protection the important weight and priority they deserve. 4 February 2014

The US trade group the Generic Pharmaceutical Association (GPhA) has identified its key priorities for 2014, a year with significant opportunities to continue providing safe, affordable medicines of the highest quality that bring savings to patients and the health care system that will build on the many industry successes achieved in 2013. 4 February 2014

US generics major Mylan has launched the world's first trastuzumab biosimilar in India. The product, developed with India’s Biocon and cleared by the Drug Controller General of India last year, will be marketed by Mylan under the brand name Hertraz. 3 February 2014

French drug major Sanofi says it has filed a patent infringement suit against USA pharma firm Eli Lilly in the US District Court for the District of Delaware, alleging infringement of four patents. 31 January 2014

The imminent entry of several companies, including big pharma, small biotech and generic participants, into the global biosimilars space will propel the market towards exponential growth. 30 January 2014

Asia’s leading small-molecule contract research organization (CRO), GVK BIO, has reached agreement to acquire Aragen Bioscience, a privately held USA-based, preclinical CRO specializing in high-value biologics services. 30 January 2014

The USA’s Biotechnology Industry Organization (BIO) and the Washington Biotechnology & Biomedical Association yesterday commended the Washington State House and Senate for continuing to advance legislation designed to create a pathway for the substitution of interchangeable biologic medicines, or biosimilars. 23 January 2014

India-based biotech firm Biocon (BSE: 532523) has introduced Canmab, a biosimilar trastuzumab, for the treatment of HER2-positive metastatic breast cancer in India. 20 January 2014

Biosimilar drugs, also known as follow-on biologics, may soon be substituted in place of the reference pharmaceutical product in Brazil, under the latest initiative launched by Brazil's National Health Surveillance Agency (ANVISA), writes Juliane Carvalho on Brazil Pharma News 17 January 2014

South Korean biopharmaceutical firm Celltrion has received approval for its cancer treatment biosimilar monoclonal antibody Herzuma (trastuzumab), Swiss drug major Roche’s blockbuster cancer drug Herceptin, from Korea’s Ministry of Food and Drug Safety. 16 January 2014

The gastrointestinal (GI) therapeutics market for irritable bowel syndrome (IBS), ulcerative colitis (UC) and Crohn’s disease (CD) in the eight major markets (8MM) - the USA, UK, France, Germany, Italy, Spain, Canada and Japan - is expected to decrease in value from $6.8 billion in 2012 to $6.6 billion by 2019, at a negative compound annual growth rate (CAGR) of 0.3%, forecasts business intelligence provider GBI Research. 16 January 2014

Health care giant Johnson & Johnson’s Janssen Pharmaceutical companies have submitted a Citizen Petition to the US Food and Drug Administration, calling on the agency to require biosimilars to bear non-proprietary names that are similar to, but not the same as, those of their reference products or of other biosimilars. 9 January 2014

China’s Walvax Biotech has revealed it plans to acquire a controlling 64% equity stake in Shanghai’s Genor BioPharma via two transactions, paying a total of 290 million renminbi (around $49 million), according to news sources including GenePool. 31 December 2013

The US Federal Trade Commission announced its one-day public workshop on competition and follow-on biologics, or biosimilars, has been rescheduled for February 4, 2014. 31 December 2013

Sandoz, the generics unit of Swiss drug major Novartis (NOVN: VX), has initiated a Phase III clinical trial with its biosimilar version of US drugmaker AbbVie’s (NYSE: ABBV) Humira (adalimumab). 19 December 2013

Biosimilars will be quickly acquired and used in public health institutions in the treatment of patients with rheumatoid arthritis (RA) in Brazil and Mexico, which both have powerful mechanisms that drive use of lower cost options. 19 December 2013

Brazil's National Health Surveillance Agency, ANVISA has signed a memorandum of technical and operational cooperation with the Brazilian Association of Manufacturers of Generic Drugs (ProGenericos) which provides for study, research, information sharing, planning and common interest projects planning, writes Juliane Carvalho on Brazil Pharma News. 18 December 2013

US biotech major Biogen Idec has exercised its right to enter into an agreement to commercialize anti-TNF biosimilar product candidates in Europe, including biosimilars for widely used therapies to treat conditions such as rheumatoid arthritis and Crohn’s disease, with its South Korea-based based joint venture Samsung Bioepis. 17 December 2013

South Korean oncologists are significantly less familiar with biosimilars than oncologists surveyed in Europe. This finding is despite the fact that South Korea has had an approval pathway for biosimilars since 2009 and the world’s first biosimilar monoclonal antibody, Celltrion’s Remsima (infliximab), was launched in South Korea. 16 December 2013

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