Other Updates

On 18 May 2026, Accord BioPharma announced that the FDA has approved Immgolis™ and Immgolis Intri™ (golimumab) as interchangeable biosimilars to Janssen’s Simponi® and Simponi® Aria, respectively.  These are the first golimumab biosimilars to be approved in the US.

The BLA for Bio-Thera/Accord’s golimumab biosimilar was accepted by the FDA for review in July 2025, which followed FDA acceptance of Alvotech/Teva’s BLA for AVT05 (golimumab) in January 2025.  However, Alvotech/Teva’s approval was delayed by a Complete Response Letter issued in November 2025, following which Alvotech undertook a “remediation project”.  Alvotech plans to resubmit its golimumab BLA to the FDA in Q2/2026.

Immgolis™ and Immgolis Intri™ were developed by Bio-Thera Solutions as BAT2506.  In February 2025, Bio-Thera and Intas Pharmaceuticals entered into an exclusive US commercialisation and licence agreement for BAT2506, under which Intas’ subsidiary Accord BioPharma is responsible for commercialising the product in the US, while Bio-Thera retains responsibility for development, manufacturing and supply.

The US launch date for Immgolis™ and Immgolis Intri™ is uncertain given ongoing US litigation relating to BAT2506.  In March 2026, Janssen commenced BPCIA patent infringement proceedings against Bio-Thera Solutions/Accord BioPharma alleging infringement of 17 patents.  A preliminary injunction application by Janssen is due to be heard in August or the beginning of September 2026.

Bio-Thera received a positive CHMP opinion in December 2025 for BAT2506, which was EU approved in February 2026 under the name Gotenfia®.  Gotenfia® is commercialised in the EU and UK by STADA.

On 15 May 2026, Roche subsidiary Genentech announced that the FDA has approved Tecentriq® (atezolizumab) and Tecentriq Hybreza® (atezolizumab and hyaluronidase-tqjs) as adjuvant treatment for adults with muscle-invasive bladder cancer (MIBC) who have circulating tumour DNA molecular residual disease (ctDNA MRD) after cystectomy, as identified by a specified MRD assay.

This is the eleventh indication approved for Tecentriq® in the US since 2016, with the drug’s approved indications also including non-small cell lung cancer, hepatocellular carcinoma and melanoma.  Tecentriq Hybreza®, the subcutaneously administered form of the drug, was approved in the US in September 2024.

No atezolizumab biosimilars have been approved to date.

On 15 May 2026, the FDA approved BMS/Daiichi Sankyo’s Enhertu® (fam-trastuzumab deruxtecan-nxki) for two separate breast cancer indications.  The indications are:

• followed, by taxane, trastuzumab and pertuzumab (THP) for neoadjuvant treatment of adults with HER-2 positive Stage II or III breast cancer, as determined by an FDA-authorised test; and
• for the adjuvant treatment of adults with HER2-positive breast cancer who have residual invasive disease following neoadjuvant treatment with trastuzumab (with or without pertuzumab) and taxane.

The first approval globally for Enhertu® for neoadjuvant treatment of HER2-positive early stage breast cancer came in March 2026 in China.  Enhertu® has previously been approved for patients with HER2-positive metastatic breast cancer in more than 95 countries, including the US (2025).

Enhertu® is the subject of a March 2019 collaboration between AstraZeneca and Daiichi Sankyo, under which the companies jointly develop and commercialise trastuzumab deruxtecan globally, except in Japan where Daiichi Sankyo maintains exclusive rights.  Following the latest US breast cancer approvals, AstraZeneca is due to pay Daiichi Sankyo a milestone payment of US$155 million.

Samsung Epis announced in January 2026 that Samsung Bioepis is adding a trastuzumab deruxtecan biosimilar to its pipeline, with the biosimilar in the early development stage in preparation for preclinical trials.

On 15 May 2026, Sandoz announced that the European Commission has granted marketing authorisation for Bysumlog®, biosimilar to Eli Lilly’s Humalog® (insulin lispro), and Dazparda®, biosimilar to Novo Nordisk’s NovoRapid® (insulin aspart).  Both biosimilars are approved for the treatment of diabetes across all indications of the respective reference products and received a positive CHMP opinion in February 2026.

Bysumlog® and Dazparda® were developed by Beijing-headquartered Gan & Lee Pharmaceuticals.  Under a December 2018 commercialisation agreement, Gan & Lee is responsible for development, manufacture and supply of insulins aspart, lispro and glargine, and Sandoz has commercialisation rights to the products in Europe and other key territories, including Japan, South Korea, Canada, Australia and New Zealand.

The only other insulin lispro biosimilar approved in Europe is Sanofi’s “Insulin lispro Sanofi”, which was approved in 2017 (known as Admelog® in the US).  Insulin aspart biosimilars approved in Europe are Biocon’s Kirsty® (previously Kixelle®) (approved February 2021) and Insulin aspart Sanofi (approved June 2020).

On 15 May 2026, Alteogen announced that the Korean Ministry of Food and Drug Safety (MFDS) has granted marketing authorisation for Eyzanfy™/ALT-L9 (aflibercept), biosimilar to Regeneron/Bayer’s Eylea® 2mg, for all approved reference indications.  The approval comes 20 months after Alteogen submitted its Korean marketing authorisation application in September 2024.

ALT-L9 is the first biosimilar developed by Alteogen.  It was approved in Europe as Eyluxvi® in September 2025, following a positive CHMP opinion in July 2025.

The first aflibercept biosimilar was approved in Korea in February 2024 – Samsung Bioepis’ Afilivu®, marketed by Samil Pharmaceutical.  Celltrion’s Eydenzelt™ (CT-P42) received Korean approval in May 2024 followed by Sam Chun Dang’s SCD411 (aflibercept) in September 2025.

Less than one month after receiving approval for generic equivalents of Novo Nordisk’s Ozempic® in Canada, Apotex and Dr Reddy’s have launched their generic semaglutide products on the Canadian market.

Apotex announced its launch of Apo-Semaglutide Injection™ on 14 May 2026, stating that initial inventory is available and is shipping to wholesalers and that the product will be on pharmacy shelves in Canada “within the coming weeks”.  Dr Reddy’s Canadian launch announcement quickly followed on 16 May 2026, with the company stating that the launch of its “Semaglutide Injection” demonstrates “Dr Reddy’s readiness to ensure patient access following approval”.  Both products are indicated for adults with type 2 diabetes and are supplied in pre-filled pens.

Dr Reddy’s was one of the first companies to receive approval for, and launch, generic semaglutide in India (under the name Obeda™).  Meanwhile, Apotex received the first US FDA Tentative Approval for its generic semaglutide ANDA, giving it an opportunity to be one of the first to launch generic Ozempic® in the US following expiry of Novo Nordisk’s exclusivity/patents.

It has previously been reported that Health Canada is reviewing numerous submissions for generic semaglutide, including applications by Teva, Aspen Pharmacare, Taro Pharmaceuticals and Sandoz (which is planning a 2026 generic semaglutide launch in Canada).  Further generic semaglutide approvals and launches are therefore expected in Canada in the coming months.

On 13 May 2026, Zydus Lifesciences announced that it has entered into a definitive agreement to acquire all outstanding shares of Assertio Holdings in an all-cash transaction valued at US$166.4 million.

Under the terms of the merger, Zydus will commence a tender offer to acquire the outstanding Assertio common stock.  Following successful completion of the tender offer, Zydus will acquire all remaining shares through a second-step merger at the same price as the tender offer (US$23.50 per share).  The transaction is expected to close in FY26/27.

Assertio’s portfolio includes Rolvedon® (eflapegrastim-xnst), which has received approval from the FDA for the prevention of febrile neutropenia in adult cancer patients receiving myelosuppressive chemotherapy.  This acquisition will expand Zydus’ oncology capabilities and presence in the US.

Zydus entered the US biosimilar market in December 2025, with an exclusive licensing and supply agreement with Formycon for the commercialisation of biosimilar pembrolizumab, FYB206.  Zydus has expressed its optimism that it will be the first company to file a BLA in the US for biosimilar pembrolizumab.  Also in December 2025, Zydus partnered with Bioeq in relation to the US commercialisation rights to Nufymco®, an interchangeable biosimilar to Genentech’s Lucentis® (ranibizumab).

On 12 May 2026, Bristol Myers Squibb (BMS) and Hengrui Pharma announced that they have entered into global strategic collaboration and licence agreements to advance 13 early stage innovative medicines across oncology, haematology and immunology.  The transaction is expected to close in Q3/2026.

The agreements include the following unnamed products: four oncology/hematology assets from Hengrui, four immunology assets from BMS, and five innovative assets to be jointly discovered and developed.

Hengrui Pharma is the largest publicly listed pharmaceutical company in China (by market value).  Its therapeutic areas of focus include oncology, metabolic and cardiovascular diseases, immunological and respiratory disease, and neuroscience.

Under the terms of the agreement, BMS has the exclusive global rights to the Hengrui assets outside of mainland China, Hong Kong and Macau.  Hengrui has the exclusive rights to the BMS assets within its territory, with BMS retaining rights for the rest of the world.  Hengrui is responsible for early clinical development.

BMS is required to pay Hengrui up to US$950 million, including a US$600 million upfront payment, a US$175 million first anniversary payment and a contingent US$175 million second anniversary payment.  Hengrui is eligible to receive tiered royalties on net sales of BMS-commercialised products.  The potential total value of the agreement is up to approximately US$15.2 billion.

On 12 May 2026, Celltrion announced that it has acquired a 100% stake in France-based healthcare firm, Gifrer.  Gifrer operates more than 9,000 pharmacy sales channels and supply networks covering about 800 hospitals across France and will continue to operate independently post-acquisition.

The acquisition is aimed at strengthening Celltrion’s access to French pharmacy channels as France expands pharmacist-led biosimilar substitution.  This includes anticipated approval for substitution of denosumab biosimilars later this year, with Celltrion planning to use Gifrer’s sales network to expand pharmacy sales for its denosumab biosimilars, Stoboclo® and Osenvelt®.

In addition, the acquisition expands Celltrion’s product portfolio beyond biopharmaceuticals, as Gifrer sells over 140 over-the-counter medicines and other health products.  Celltrion expects the acquisition to generate an additional 250 billion won in revenue over the next 5 years.

On 12 May 2026, the US Patent Trial and Appeal Board (PTAB) issued a final written decision invalidating Halozyme’s US Patent No. 11,952,600 relating to modified PH20 hyaluronidase polypeptides.  The patent is one of a number of patents relating to Halozyme’s MDASE™ technology, that Halozyme has alleged in US court proceedings is infringed by MSD’s subcutaneous pembrolizumab (Keytruda Qlex™/ Keytruda SC™).

MSD filed a petition requesting post-grant review of all claims of the US ‘600 patent in November 2024 and the review was instituted in June 2025.  Halozyme subsequently disclaimed claims 5-7, leaving claims 1-4 and 8-21 in effect.  The PTAB determined that each of those claims was invalid for lack of enablement and failure to comply with the written description requirement.

Between November 2024 and November 2025, MSD filed petitions for post-grant review with the US Patent Trial and Appeal Board challenging the validity of 14 other Halozyme patents.  13 of those petitions have been instituted, while institution of the 14^th was denied on 15 May 2026.  In addition, in March 2026, MSD filed inter partes review (IPR) petitions in relation to a further three Halozyme patents, which are pending and have not yet been instituted.

Halozyme has sued MSD in the US in relation to SC pembrolizumab.  In a complaint filed with the US District Court for the District of New Jersey on 24 April 2025, Halozyme alleged that Keytruda Qlex™ infringes 15 patents owned by Halozyme in relation to the MDASE™ subcutaneous delivery platform.  The lawsuit followed reports in March 2025 that Halozyme had offered MSD an opportunity to licence its MDASE patents.  At the time, a spokesperson from MSD said the enzyme used in Keytruda Qlex™ was “developed independently” from Halozyme and that MSD “strongly believes” that any Halozyme patents that attempt to cover the enzyme variant are invalid.

The Halozyme patents currently the subject of US litigation and PGR or IPR proceedings are as follows:

In December 2025, the Munich Regional Court granted Halozyme’s application for a preliminary inunction preventing MSD from distributing and offering Keytruda SC™ for sale in Germany.  The decision was based on a finding of the Court that there was imminent infringement of one of Halozyme’s European MDASE™ patents, EP 2797622, in relation to modified PH20 hyaluronidase polypeptides and compositions.  MSD has filed invalidation lawsuits against the same Halozyme European patent in four countries: Germany, the United Kingdom, the Netherlands, and France.

MSD’s subcutaneous formulation of pembrolizumab was approved in the US, as Keytruda Qlex™, in September 2025 across 38 indications.