On 21 March 2026, multiple generic semaglutide products launched on the Indian market, proclaiming “Day 1 entry” on expiry of Novo Nordisk’s core Indian patent for semaglutide (Ozempic®/Wegovy®).

The products launched on the Indian market include:

• Dr Reddy’s injectable semaglutide, launched under the name Obeda™, in a pre-filled disposable pen for type 2 diabetes. According to Dr Reddy’s, it was the first Indian company to receive approval from the Drugs Controller General of India (DCGI) for generic semaglutide.  The cost to the patient will be about INR 4,200 per month.
• Zydus Lifesciences’ Semaglyn™, Mashema™ and Alterme™. Zydus’ injectable semaglutide received DCGI approval for the treatment of both Type 2 diabetes mellitus and obesity.  The products are available in a reusable, multi-dose pen device.  The average monthly cost of the treatment will be approximately INR 2,200.  Under an agreement announced on 17 March 2026, Lupin holds semi-exclusive rights to co-market Zydus’ semaglutide injection under the brand names Semanext® and Lupin’s Livarise®.
• Alkem Laboratories’ semaglutide injection, launched under the names Semasize™, Obesema™ and Hepaglide™. It is available in a pre-filled disposable injection pen at a price starting at INR 1,800 for a month’s dosage, which amounts to a weekly cost of about INR 450.  A reusable pen option is also available.  Alkem received DCGI approval for type 2 diabetes mellitus and chronic weight management as an adjunct to diet and exercise, subsequent to a review of its Phase 3 clinical trials conducted in India.
• Sun Pharma’s Noveltreat™ and Sematrinity™ (semaglutide), indicated for chronic weight management and type 2 diabetes mellitus, respectively. Noveltreat™ is available in a pre-filled pen, while Sematrinity™ is provided in a multi-dose pen format.  Weekly therapy costs (from initiation to the highest dose) range from about INR 900 to 2,000 for Noveltreat™ and INR 750 to 1,300 for Senatrinity™.
• Glenmark Pharmaceuticals’ GLIPIQ®, for the management of Type 2 diabetes mellitus. The drug received DCGI approval in both vial and pre-filled pen formulations. The expected weekly cost of treatment with GLIPIQ® vials ranges from INR 325 to INR 440.

According to Indian-English language newspaper, The Hindu, the market for semaglutide in India is estimated to be $1 billion over the next two years, with an estimate of over 100 million people in India having diabetes and an additional 136 million being pre-diabetic.

On 20 March 2026, Novo Nordisk announced that the FDA has approved its 7.2mg semaglutide injection, Wegovy® HD, for the reduction of excess body weight and maintenance of weight reduction long-term.  The high dose formulation is expected to be launched in the US in a single dose pen in April 2026.

Wegovy® HD received accelerated approval under the FDA Commissioner’s National Priority Voucher (CNPV) pilot program, which accelerates review and approval of products that align with a certain critical US national health priority.  Novo Nordisk’s supplemental New Drug Application for the product was submitted in November 2025.

Wegovy® 7.2mg has been approved in the EU (positive CHMP recommendation in December 2025, European Commission approved February 2026) and the UK (approved January 2026) as maintenance doses for adults with obesity.  Novo Nordisk expects regulatory decisions in the EU and the UK regarding a single-dose 7.2mg semaglutide pen in the second half of 2026.

On 20 March 2026, Celltrion announced that it has obtained additional approval from Health Canada for an autoinjector formulation of Steqeyma®, biosimilar to Janssen’s Stelara® (ustekinumab).  This approval enables Celltrion to launch two additional autoinjector formulations (45mg/0.5mL and 90mg/1.0mL) in Canada.

Canada has seen significant biosimilar activity for ustekinumab.  The following products have already been approved by Health Canada:

The US market has seen an even bigger wave of ustekinumab biosimilar activity in 2025.  By the end of the year, the FDA had approved a total of eight ustekinumab biosimilars.  The following biosimilars launched in the US during 2025:

On 20 March 2026, BMS announced that Opdivo® (nivolumab) has received approvals from the FDA, in combination with doxorubicin, vinblastine and dacarbazine (AVD) for the treatment of previously untreated, Stage III or IV classical Hodgkin Lymphoma (cHL) and from the European Commission, in combination with brentuximab vedotin for the treatment of relapsed or refractory cHL after one prior line of therapy.  The European approval was recommended in January 2026.  The US approval follows the FDA’s priority review.

On the same date, Shanghai Henlius Biotech announced it has received approval from China’s National Medical Products Administration (NMPA) for the investigational new drug (IND) application for HLX18, biosimilar to Opdivo®.  This follows the US FDA approval of the IND application for HLX18 in December 2025.

A number of other nivolumab biosimilars have been launched or are in development.  Zydus was recently first to market its biosimilar, Tishtha®, in India.  At least Amgen, Sandoz, Xbrane/Intas, Boan Biotech, Enzene, Reliance Life Sciences and Biocon have nivolumab biosimilars in their pipelines.

On 19 March 2026, Chugai Pharmaceutical (a Roche subsidiary) announced that it filed a regulatory application with Japan’s Ministry of Health, Labour and Welfare for the medical device component of its Port Delivery Platform with ranibizumab.

The Port Delivery Platform comprises an ocular implant designed for the long-term, continuous release of a drug into the eye (in this case, ranibizumab).  The platform includes the implant and an insertion device, as well as ancillary devices (initial fill needle, refill needle, and explant tool).

Chugai’s regulatory application is based on the global Phase III Archway study results in patients with neovascular age-related macular degeneration (nAMD), and the global Phase 3 Pagoda study in patients with diabetic macular oedema (DME), both conducted in the US by Genentech/Roche, using their Susvimo® (ranibizumab).

Chugai’s announcement follows Genentech/Roche’s announcement in February 2025 that the FDA approved a new indication for Genentech’s Susvimo® (ranibizumab, 100 mg/ml injection) for diabetic macular oedema (DME), making it the first and only approved continuous delivery treatment for DME.  The approval was based on one-year results from the Phase 3 Pagoda study.

The FDA had first approved Susvimo® in October 2021.  However, in October 2022, Genentech launched a voluntary recall after test results showed some implants did not perform to Genentech’s standards.  Genentech has since updated the Susvimo® implant and refill needle.  DME is the second indication approved for Susvimo®, after the FDA approved its relaunch for nAMD in July 2024.

During its Q4/2025 Earnings Call on 19 March 2026, Alvotech provided updates on its launch plans and regulatory applications for various biosimilars, including golimumab, aflibercept, vedolizumab and pembrolizumab.

Alvotech confirmed that Gobivaz® (AVT05) was launched in the EU in December 2025 as the first available biosimilar to J&J’s Simponi® (golimumab), following its November 2025 EU marketing authorisation.  Gobivaz® is being commercialised by Advanz Pharma in the UK and Europe under a May 2023 licence and supply agreement with Alvotech.  In Japan, Alvotech’s commercialisation partner, Fuji Pharma, is planning to launch Gobivaz® (approved in September 2025) in May 2026.  An application for approval of AVT05 has also been filed in Canada, with a decision expected in H1 2026.  To date, the application for AVT05 is the only known golimumab biosimilar application filed in Canada.

Alvotech indicated that it is aiming to file the first regulatory submission for its high dose aflibercept biosimilar, AVT29, sometime in 2026.  AVT29, biosimilar to Regeneron/Bayer’s Eylea™ 8mg/Eylea HD®, will be commercialised by Advanz Pharma in the EU and by Teva in the US.  Under settlement agreements with Regeneron/Bayer, Alvotech has a Q4/2026 US launch date for AVT06 (biosimilar to Regeneron/Bayer’s Eylea® (aflibercept), 2mg), subject to FDA approval, and various 2026 launch dates, with its partners STADA and Advanz Pharma having already launched AVT06 in Germany (under the name Afiveg®) and in the UK, Canada and Japan (under the name Mynzepli®), respectively.

Following the recent announcement of positive results from its PK study for AVT80, biosimilar to Takeda’s Entyvio® (vedolizumab), Alvotech said that it is planning to file regulatory submissions for a vedolizumab biosimilar later in 2026.  Alvotech expects to be among the first to launch an Entyvio® biosimilar and has both IV (AVT16) and SC (AVT80) formulations in development.

As previously reported, Alvotech has a biosimilar to MSD’s Keytruda® (pembrolizumab) in its pipeline, on which it is partnering with Dr Reddy’s.  During the Q4 2025 Earnings Call, Alvotech said that it is expecting it will be in a position to file a marketing authorisation application for the pembrolizumab biosimilar in 2028.

Alvotech also provided an update on the Complete Response Letters it received from the FDA in relation to its denosumab, golimumab and aflibercept biosimilars, announcing that it has undertaken a remediation project and is on track to resubmit its applications to the FDA in the first half of 2026.

On 19 March 2026, Formycon and Klinge announced they have entered into a settlement and licence agreement with Regeneron/Bayer for FYB203, biosimilar to Regeneron/Bayer’s Eylea® (aflibercept), 2mg, in Europe and key markets in the Latin American and Asia-Pacific regions.  The agreement permits launch of FYB203 in Europe and the other licensed regions from May 2026.  FYB203 is set to launch in the US in Q4/2026 following a separate settlement of BPCIA litigation in October 2025.

The recent settlement resolves all EU patent disputes related to FYB203, including in Germany where, in October 2025, the Munich Regional Court granted Regeneron a permanent cross-border injunction against Formycon preventing the launch of FYB203 across 20 European countries until the expiry of Regeneron’s aflibercept formulation patent EP2364691.  There have also been legal proceedings in relation to FYB203 in at least the UK, Italy, Belgium, the Netherlands, and France.

FYB203 received European marketing approval in January 2025 under the brand names Ahzantive® and Baiama®.  It was developed by Formycon, and Klinge holds the exclusive commercialisation rights.

Klinge has entered into agreements with Teva Pharmaceuticals for the semi-exclusive commercialisation rights to FYB203 (as Ahzantive®) in Europe (excluding Italy) and Israel (January 2025), Horus Pharma for the semi-exclusive commercialisation rights to FYB203 (as Baiama®) in selected European countries (September 2025) and NTC for the exclusive commercialisation rights to FYB203 in Italy (November 2025).

In the Asia Pacific region, Formycon/Klinge have exclusively licensed FYB203 commercialisation rights to Lotus Pharma for various Asian countries (February 2025) and to Actor Pharmaceuticals for Australia (October 2025).  A patent revocation action brought by Actor Pharmaceuticals in Australia relating to Regeneron’s method of treatment patent AU2012205599 relating to Eylea® (with a cross-claim for infringement by Regeneron/Bayer) was discontinued by consent on 18 March 2026, presumably in connection with the recent settlement.

In Latin America, Klinge has exclusively licensed the FYB203 commercialisation rights to Uruguay-based Megalabs (October 2025).  According to Formycon, it has been working closely with Megalabs to prepare marketing applications for Latin American countries.

Biosimilars of Regeneron/Bayer’s Eylea® 2mg are already on the market around the world, including, for example, Alvotech’s Mynzepli® (launched in the UK, Canada and Japan), Amgen’s Pavblu® (available in the US), Sandoz’s Afqlir®/Enzeevu® (launched in the UK, Australia and Canada), Samsung Bioepis’ Afilivu®/Opuviz® (available in Korea) and Celltrion’s Eydenzelt® (launched in the UK and Europe).

On 18 March 2026, Sandoz announced it has entered into a licence, development and commercialisation agreement with Samsung Bioepis for up to five biosimilars, including vedolizumab.

Under the agreement, Sandoz will have exclusive rights to commercialise the biosimilars globally (excluding China, Hong Kong, Taiwan, Macau and the Republic of Korea), while Samsung Bioepis will be responsible for development, manufacturing and regulatory submissions in key markets.

The first biosimilar to be licensed under the agreement will be a biosimilar to Takeda’s Entyvio® (vedolizumab).  In January 2026, Samsung Bioepis announced that it had a vedolizumab biosimilar under early-stage development.

Sandoz and Samsung Bioepis previously entered into a development and commercialisation agreement in September 2023 for Pyzchiva®/SB17, biosimilar to J&J’s Stelara® (ustekinumab).  Under that agreement, Sandoz has the right to commercialise Pyzchiva® in Europe, Switzerland, the UK, the US and Brazil.  Sandoz launched Pyzchiva® in Europe in July 2024 and in the US in February 2025.

In December 2025, the companies signed a commercialisation agreement for Epysqli™, biosimilar to Alexion’s Soliris® (eculizumab), for the Middle East and Africa region.

On 17 March 2026, Celltrion announced that the subcutaneous (SC) formulation of Avtozma®, biosimilar to Roche’s Actemra® (tocilizumab), is now available in the US.  The SC formulation is approved for rheumatoid arthritis, giant cell arteritis, polyarticular juvenile idiopathic arthritis and systemic juvenile idiopathic arthritis.  Avtozma® SC formulation is available in a single-dose prefilled syringe or a single-dose prefilled autoinjector.

Both the subcutaneous and intravenous formulations of Avtozma® were FDA approved in January 2025, with the IV formulation launched in October 2025.  In December 2025, Celltrion secured reimbursement coverage for Avtozma® IV in the US, with patient reimbursement available from January 2026.

Biogen/Bio-Thera’s Tofidence®/BAT1806 (tocilizumab-bavi) was the first US approved tocilizumab biosimilar (IV formulation approved September 2023; launched May 2024), followed by Fresenius Kabi’s Tyenne® (tocilizumab-aazg) (SC formulation approved March 2024; IV formulation launched April 2024; SC formulation launched July 2024).  Fresenius Kabi’s Tyenne® SC was the first SC tocilizumab formulation to launch in the US.

Celltrion’s Avtozma® was the first tocilizumab biosimilar to be approved in Korea in December 2024.  In the same month, Avtozma® received a positive recommendation by the EMA’s CHMP and subsequently gained European Commission approval in February 2025.  The biosimilar has also been granted marketing approval in other regions, including as the first tocilizumab biosimilar approved in Australia (May 2025), Japan (September 2022) and New Zealand (December 2025).  It was recommended for listing on Australia’s Pharmaceutical Benefits Scheme at PBAC’s November 2025 meeting.

On 16 March 2026, Samsung Bioepis and its sister company, Epis NexLab, announced they have entered into a research collaboration and licence agreement with G2GBIO to develop long-acting semaglutide.  G2GBIO specialises in the development of sustained-release formulations using a “long-acting microsphere platform”.

Under the agreement, Samsung Bioepis will obtain full licence rights to the novel long-acting semaglutide and will have an option to licence another undisclosed G2GBIO asset.  Samsung Bioepis will also receive first negotiation rights for three yet-to-be-determined novel assets.  Epis NexLab will be responsible for the co-development of the long-acting microsphere drug delivery platform using G2GBIO’s proprietary technology.

There has been growing interest in the semaglutide space as key Novo Nordisk patents are set to expire in multiple markets in 2026, including India, China and Canada.  In January 2026, Sun Pharma, Zydus Lifesciences and Alkem Laboratories received approval in India to manufacture and sell generic versions of Novartis’ Wegovy® and Ozempic®.  According to Zydus, it plans to launch its Semaglutide Injection (15mg/3ml) in India under the brand names Semaglyn™, Mashema™ and Alterme™ “upon semaglutide patent expiry” on 20 March 2026.