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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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Privately-held Alvotech today announced it is entering into a joint venture with China’s Changchun High & New Technology (CCHN) Industries Group, which will enable Iceland-based Alvotech to develop, manufacture and commercialize its biosimilar portfolio in China. 27 September 2018

The European Medicines Agency has approved Pelgraz (pegfilgrastim) and in some countries it could be in the hands of healthcare professionals this week, making it the first biosimilar of Amgen’s (Nasdaq: AMGN) Neulasta to reach patients in Europe. 26 September 2018

The prospect of reducing treatment costs for payors supports a positive future for biosimilars, according to new research released today. 20 September 2018

The USA’s slow uptake of biosimilars compared to Europe and other markets has not helped to bring down the country’s notoriously high drug prices. 17 September 2018

As AbbVie continues to fend of biosimilars competition in the USA for to its mega-blockbuster drug Humira (adalimumab), new data presented at the European Association of Dermatology and Venereology Annual Meeting (EADV 2018) in Paris further support another strong competitor. 12 September 2018

South Korean firm Celltrion Healthcare has called on the UK’s public healthcare provider, the National Health Service (NHS), to consider lowering the threshold for starting biologics in patients with rheumatoid arthritis (RA). 4 September 2018

AryoGen Pharmed has become the first manufacturer of monoclonal antibody (MAb) biologics in the Middle East and North Africa (MENA) region to receive good manufacturing practice (GMP) certification from the European Medicines Agency (EMA). 3 September 2018

A lawyer’s look into the competition provided by biosimilars to biologic therapies has highlighted how this contest differs from generic competitors challenging branded drugs. 29 August 2018

While Indian drugmakers have been hugely successful in the generics arena, if they want to succeed in the potentially more lucrative biosimilars sector, they need to look at acquisitions and partnering, a new study reveals. 14 August 2018

Biosimilars

The FDA's Biosimilar Action Plan

The world’s total expenditure on medicines was $1.135 trillion in 2017 and is projected to reach $1.4 trillion in 2022.1 Understandably, when contemplating such large figures, the reaction from governments, healthcare payers and the public has been to seek more value for every dollar spent, writes Dr Nicola Davies on her regular blog for The Pharma Letter. 13 August 2018

Generic and specialty pharmaceuticals firm Mylan has announced lower than expected second quarter revenues of $2.81 billion, down 5% compared to the prior year period. 8 August 2018

The UK's Department for Health has launched a consultation on its plans to begin applying price controls to biosimilars, proposals that have promptly been ridiculed. 7 August 2018

German generics major Stada Arzneimittel is increasing its presence in the important biosimilar sector by taking a majority stake in an affiliate. 6 August 2018

One small step for biosimilars, one notable leap for Pfizer. 31 July 2018

Indian biopharma company Intas Pharmaceuticals' wholly-owned subsidiary Accord Healthcare is set to be the first integrated player to launch a pegfilgrastim biosimilar across Europe after nearly being given the regulatory green light for Pelgraz (pegfilgrastim). 31 July 2018

Sandoz, a division of Swiss pharma titan Novartis, announced on Friday that it had received marketing authorization from the European Commission for its biosimilar equivalent of AbbVie's Humira (adalimumab). 30 July 2018

In what was clearly a bumper session for the regulator, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended 16 medicines for approval at its July 2018 meeting. 28 July 2018

There was a sigh of relief last week, when UK Members of Parliament voted for ongoing participation in the European Medicines Agency. On the regulatory front, there was good news for Advaxis when the US Food and Drug Administration lifted the clinical hold on a cancer drug combination axalimogene filolisbac (AXAL) in combination with durvalumab. Also, the FDA’s ‘Biosimilars Action Plan’ is seen as a positive step in the chase for value-based pricing. In terms of clinical trials, Roche’s latest flu drug baloxavir marboxil is showing promise. Biogen was up on positive new data on BAN2401, an Alzheimer’s drug candidate which was largely written off, and Allergan and Molecular Partners achieved positive results with abicipar in wet age-related macular degeneration. 22 July 2018

On Friday, the US Food and Drug Administration approved Nivestym (filgrastim-aafi), a biosimilar to Neupogen (filgrastim), for all eligible indications of the reference product and follows marketing authorization in Europe in 2010. 21 July 2018

US drugmaker AbbVie has entered patent license agreements with Mylan over its proposed biosimilar to AbbbVie’s mega-blockbuster drug Humira (adalimumab). 17 July 2018

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