In Brief

Refine Search

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

12 3 4 5 Next page

Swiss generics and biosimilars drugmaker Sandoz today announced net sales for the first quarter 2024 of $2.5 billion, an increase of 6% in constant currencies compared to the same quarter of the prior year. 7 May 2024

The first drug for the treatment of ankylosing spondylitis has been registered in the Russian Federation, according to the country’s Ministry of Health and local media reports. 7 May 2024

The biopharmaceutical industry has been buzzing over the US government's unveiling of the BIOSECURE bill. 3 May 2024

The US Food and Drug Administration (FDA) has approved the high-concentration, citrate-free formulation of Cyltezo (adalimumab-adbm). 1 May 2024

Swiss generic and biosimilar medicines company Sandoz has reached agreement with US biotech major Amgen to resolve all patent disputes between the two companies relating to the former company’s US Food and Drug Administration (FDA)-approved denosumab biosimilars. 30 April 2024

As over 20 drugs with a combined annual sales value of $250 billion are set to go off-patent, Indian companies have been exhorted to step in with generic and biosimilar versions. 30 April 2024

On April 25, the US Food and Drug Administration (FDA) approved the 50th biosimilar for marketing in the USA. 29 April 2024

South Korean Celltrion saw its shares lifted 4% to 183,700 won today, after it announced that its US subsidiary has signed an agreement with Express Scripts. 29 April 2024

The European Medicines Agency’s (EMA) human medicines committee (CHMP) recommended five novel medicines for approval at its April 2024 meeting, as well as two biosimilars. 27 April 2024

On Wednesday, the US Food and Drug Administration (FDA) announced a revised draft guidance to answer questions biologics companies may have when developing promotional communications for prescription biologics including reference products, biosimilars, and interchangeable biosimilars. 25 April 2024

The European Commission (EC) has granted marketing authorization for Pyzchiva (biosimilar ustekinumab), said Swiss generics and biosimilars company Sandoz. 22 April 2024

Former Italian Prime Minister Enrico Letta has stressed the importance of access to medicines in a report on what is next for Europe’s single market.Former Italian Prime Minister Enrico Letta has stressed the importance of access to medicines in a report on what is next for Europe’s single market. Equity of medicine access, sustainable pricing and procurement models for supply and European Union (EU)-wide funds for domestic investments in medicine manufacturing are all encouraged in the Report on the Future of the Single Market. The Letta Report calls on the EU to strengthen the market to improve access to medicines, building on the EU Pharmaceutical Strategy. Timely patient access to more generic and biosimilar medicines should be priorities in the legislative review and in the next institutional cycle. It is proposed to leverage public procurement to promote social value, enhance social capital and align with the EU's green and digital transformation ambitions. As underlined in the report, reliance on the lowest price award criterion results in inefficiencies, such as medicine shortages, and fails to address environmental goals. The report also calls for the support of investment in medicines manufacturing for an open strategic autonomy by adapting state and regional aid rules while ensuring that investment support can be spread widely across the EU. With production sites in all EU countries, there is support from industry for this approach for a future Critical Medicines Act and for a Biotech Industry Act. Adrian van den Hoven is director general of Medicines for Europe, a trade group which represents the generic, biosimilar and value-added medicines industries. He said: “Mr Letta has rightly put a strong focus on healthcare in his report. The single market for pharmaceuticals should ensure equitable access to medicines, integrate security of supply criteria into market policies and bolster manufacturing competitiveness especially for generic, biosimilar and value-added medicine supply chains. “The comprehensive strategy outlined in the report should be prioritized in EU policies, securing adequate funding for manufacturing, enhancing security of supply in procurement and ensuring timely access to generic, biosimilar and value-added medicines for equitable access.” The full report is available here. 19 April 2024

A division of Medicines for Europe, the trade group representing the region's generics and biosimilars firms, has called for a new strategy to promote the biosimilars sector. 18 April 2024

The Icelandic-Israeli pairing of Alvotech and Teva Pharmaceutical Industries have announced that the US Food and Drug Administration (FDA) has approved Selarsdi (ustekinumab-aekn) injection for subcutaneous use. 17 April 2024

Germany’s Fresenius - via its operating company Fresenius Kabi - has announced the immediate US availability of Tyenne (tocilizumab-aazg), a biosimilar of Roche’s Actemra (tocilizumab). 16 April 2024

The USA-based Biosimilars Council, the leading trade association representing manufacturers of biosimilar medicines, has released a new analysis of IQVIA data revealing health plans and patients missed out on savings up to $6 billion as a result of rebate schemes by pharmacy benefit managers. 9 April 2024

South Korean drugmaker Samsung Bioepis today released its Second Quarter 2024 Biosimilars Market report, which includes the latest average sales price (ASP) information of all biosimilars and reference products available in the US market. 8 April 2024

Israel-headquartered drugmaker Teva Pharmaceutical Industries and Spain-based mAbxience have entered a strategic licensing agreement for a biosimilar candidate currently in development for the treatment of multiple oncology indications. 5 April 2024

The landscape of biosimilars has rapidly evolved over the past decade, with the US Food and Drug Administration (FDA) spearheading efforts to enhance their approval and utilization. 3 April 2024

The European Commission (EC) has approved an expanded indication for South Korean drugmaker Samsung Bioepis’ Epysqli. 27 March 2024

Previous page 1 2 345 6 7 8 9 10 Next page

In Brief

Today's issue

Company Spotlight