On 29 April 2026, the European Commission approved Shanghai Henlius and Organon’s Poherdy® (pertuzumab) as the first biosimilar to Genentech/Roche’s Perjeta®.

Poherdy® is indicated for use (with trastuzumab and docetaxel) in adults with HER2-positive metastatic or locally recurrent unresectable breast cancer.  The approval follows the CHMP recommendation of 27 February 2026.

Under a June 2022 deal, Organon has exclusive global commercialisation rights for Henlius’ pertuzumab and denosumab biosimilars, “except for China; including Hong Kong, Macau and Taiwan”.

Roche and Genentech settled parallel BPCIA proceedings against Shanghai Henlius and Organon relating to Poherdy® in the US in January 2026.  Poherdy® was approved by the FDA in November 2025.

Pertuzumab biosimilars have been approved in India and include Intas’ biosimilar (December 2024, subject to submission of further studies), Zydus’ Sigrima™ (June 2024, subject to ongoing litigation) and Enzene’s Pertuza®/Perzea® (launched September 2025).  In Russia, Biocad’s Pertuvia™ (May 2025) and R-Pharm’s Persinthia™ (February 2026) have been approved.  Pertuzumab biosimilars are also under development by Sandoz and EirGenix and, in February 2026, Genentech commenced US ITC proceedings against Biocon regarding its pertuzumab biosimilar, BMAB 1500.

On 1 April 2026, Shanghai Henlius Biotech announced that its Investigational New Drug (IND) application for HLX319, biosimilar to Genentech/Roche’s Phesgo® (Perjeta® (pertuzumab), Herceptin® (trastuzumab) and hyaluronidase), has been approved by China’s National Medical Products Administration (NMPA).  Shortly after, on 10 April 2026, the company reported that the first patient in its phase I clinical trial, HLX319-001, had been dosed.

HLX319 is intended for neoadjuvant/adjuvant treatment of HER2-positive early or locally advanced breast cancer, as well as for the treatment of metastatic breast cancer.  The pertuzumab and trastuzumab used in HLX319 are Henlius’ self‑developed HLX11/Poherdy® and HLX02/Hanquyou®, together with a proprietary recombinant human hyaluronidase (rHuPH20).

In February 2026, HLX11/Poherdy® (pertuzumab) received a positive CHMP opinion in Europe for use (with trastuzumab and docetaxel) in adults with HER2-positive metastatic or locally recurrent unresectable breast cancer.  It was also the first biosimilar to Genentech/Roche’s Perjeta® approved in the USA where a legal challenge was settled in January 2026.

HLX02/Hanquyou® (trastuzumab) has been approved in China since 2020, and under different names in Canada (August 2024), the US (April 2024),  Australia (July 2022), and Europe (July 2020).

On 10 March 2026, The Pharma Letter reported that Roche subsidiary, Genentech, had begun legal proceedings before the Moscow Arbitration Court alleging patent infringement by Biocad’s biosimilar to Perjeta® (pertuzumab), Pertuvia™.  Pertuvia™ was approved for sale in Russia in May 2025.

This Russian action comes shortly after Genentech commenced ITC proceedings in the US against Biocon’s pertuzumab biosimilar BMAB 1500 in February this year.

Roche and Genentech recently settled parallel BPCIA (US) proceedings against Shanghai Henlius and Organon relating to their pertuzumab biosimilar, Poherdy®.  Poherdy® was approved by the FDA in November 2025 and received a positive CHMP opinion in early 2026.

Court action by Roche against Zydus regarding its pertuzumab biosimilar, Sigrima®, have been running since the approval of that product in India in 2024.

This multiplicity of pertuzumab-related legal actions reflects Roche’s concern, expressed in mid-2025, that biosimilar competition to Perjeta® would occur sooner than previously expected.

Other pertuzumab biosimilars been approved in Russia for R-Pharm and in India for Intas and Enzene.  Further biosimilars are under development by Sandoz and EirGenix and through an Indo-Brazilian partnership.

On 27 February 2026, Genentech filed a complaint at the US International Trade Commission (ITC) alleging that Biocon’s importation of its pertuzumab biosimilar, BMAB 1500/PERT-IJS infringed four US patents: US8652474 (for pharmaceutical compositions comprising a HER2 antibody and certain acidic variants thereof); US11597776 (methods of making such compositions); US12145997 (methods for preventing reduction of disulfide bonds during an antibody manufacturing process); and US12173080 (related to US’997).  Genentech alleges that on 18 October 2025, Biocon imported more than 17,800 units of BMAB 1500 from India before it received FDA approval.  Genentech contends this conduct falls outside the safe harbour under 35 USC 271(e)(1) (allowing otherwise infringing conduct reasonably related to regulatory submissions) characterizing it as stockpiling of commercial supplies.

Genentech has recently settled US District Court litigation in which the same patents, among others, were alleged to be infringed by Henlius and Organon.

Genentech’s partner, Roche, has previously commenced legal action against a pertuzumab biosimilar in India, suing Zydus for patent infringement in the High Court of New Delhi.

On 27 February 2026, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) announced the outcomes of its February 2026 meeting, including positive opinions for 6 biosimilars: Shanghai Henlius/Organon’s Poherdy® (HLX11) (pertuzumab), Gedeon Richter’s Tuyory® (tocilizumab), Biocon’s Fubelv® (etanercept), Sandoz/Gan & Lee’s Bysumlog® (insulin lispro) and Dazparda® (insulin aspart), and CinnaGen’s Zandoriah™ (teriparatide).

Shanghai Henlius/Organon’s Poherdy® (HLX11), biosimilar to Genentech/Roche’s Perjeta® (pertuzumab), is indicated for use (with trastuzumab and docetaxel) in adults with HER2-positive metastatic or locally recurrent unresectable breast cancer.  Under a June 2022 deal, Organon has exclusive global commercialisation rights for Henlius’ pertuzumab and denosumab biosimilars, “except for China; including Hong Kong, Macau and Taiwan”.  Poherdy® received FDA approval in November 2025 and Henlius/Organon settled BPCIA litigation relating to pertuzumab with Genentech/Roche in January 2026.

Richter’s Tuyory® (RGB-19), biosimilar to Roche’s RoActemra® (tocilizumab) was recommended by CHMP across multiple indications.  Tuyory® was jointly developed by Richter and Mochida Pharmaceutical, with Mochida being responsible for regulatory filings in Japan and Richter filing marketing authorisation applications in other countries.  There are 3 tocilizumab biosimilars approved in Europe: Fresenius Kabi’s Tyenne® (November 2023), STADA’s Tocilizumab STADA™ (previously Biogen’s Tofidence®) (June 2024) and Celltrion’s Avtozma® (February 2025).

Fubelv®, biosimilar to Pfizer’s Enbrel® (etanercept) is Biocon’s second etanercept brand in the EU.  The first, Nepexto® was EU approved in 2020 (with Lupin being the marketing authorisation holder at that time).

Gan & Lee’s Bysumlog®, biosimilar to Eli Lilly’s Humalog® (insulin lispro) and Dazparda®, biosimilar to Novo Nordisk’s Novolog® (insulin aspart), will be commercialised in Europe by Sandoz under a December 2018 agreement.

CinnaGen’s Zandoriah™, biosimilar to Eli Lilly’s Forteo® (teriparatide), will join a number of other teriparatide biosimilars registered in Europe, including Richter’s Terrosa® (approved in 2017).  A previous application for EU approval of a teriparatide biosimilar was withdrawn by CinnaGen in September 2021.

In an effort to “champion equitable access to medicine” Brazil and India have entered into a series of agreements to support Brazilian domestic manufacture of publicly funded oncology medicines.

On 21 February 2026, it was announced at the India-Brazil Business Forum in New Delhi that Brazil and India have entered into three “Productive Development Partnerships” (PDPs) to “leverage state purchasing power” and domestically manufacture “crucial” oncology medicines.  Under the agreements, various oncological drugs, including biosimilars nivolumab and pertuzumab, will be produced in Brazil.  The agreements involve Brazilian public institutions and private companies, including Indian companies, and foresee technology transfer and local production.  The Brazilian Ministry of Health said that it estimates its investment will be up to US$140 million in the first year, potentially reaching US$ 1.9 billion over 10 years.

Brazilian manufacture is intended to reduce costs associated with importing complex biological compounds and to secure a steady and reliable supply that is less susceptible to international market fluctuations or logistical challenges.

Brazilian state-owned Bahiafarma will be involved in the production of both biosimilars.  The nivolumab project will also involve Brazilian company Bionovis, and India’s Dr Reddy’s Laboratories.  Pertuzumab will be produced with Bionovis and Biocon Biologics do Brasil.

In an addendum to the PDPs, Brazil and India have agreed to 5 years of further joint initiatives addressing vaccines and APIs across an array of health challenges (oncology, diabetes, cardiovascular disease, and disease prevention) with a focus on “bio-manufacturing, biologics, health digitization, telemedicine solutions, and the application of artificial intelligence in healthcare.”

Biocon and Lupin have signed technology transfer agreements with Brazil’s public health research institute Fiocruz.

Dr Reddy’s has a nivolumab biosimilar under development, while Biocon Biologics has a pertuzumab biosimilar in its pipeline.

On 2 February 2026, R-Pharm announced that the Russian Ministry of Health has approved Persinthia™, biosimilar to Genentech/Roche’s Perjeta® (pertuzumab), for the treatment of HER2-positive breast cancer.  The approval follows R-Pharm’s announcement in December 2025 at the 29th Russian Oncology Congress that Persinthia™ had completed Phase III trials.

Persinthia™ is the second pertuzumab biosimilar approved in Russia, following approval of Pertuvia™ in May 2025 by OOO-PK-137, a subsidiary of Biocad.

Shanghai Henlius/Organon’s Poherdy®/HLX11 (pertuzumab) was approved in the US in November 2025.  In January 2026, Henlius, Organon, Genentech and Roche settled BPCIA litigation in relation to the biosimilar.

Sandoz and EirGenix have a commercialisation deal in place for pertuzumab biosimilar EG1206A (November 2025) and received positive feedback from both the FDA and the European Medicines Agency, confirming that the product qualifies for an abbreviated development pathway allowing for the waiver of Phase III comparative efficacy trials.

In India, Enzene’s pertuzumab biosimilar was launched in September 2025 and is being marketed by Enzene’s parent company, Alkem Laboratories, as Pertuza®, and Hetero Healthcare as Perzea®.  Zydus’ Sigrima™ was approved in India in September 2024, but is subject to ongoing litigation.  Intas received approval for its pertuzumab biosimilar in December 2024, subject to submission of further studies.

On 30 January 2026, a Joint Stipulation of Dismissal was filed in the US District Court for the District of New Jersey dismissing all claims in the BPCIA litigation commenced by Genentech/Roche in August 2025 in relation to Shanghai Henlius/Organon’s Poherdy® (HLX11, pertuzumab), biosimilar to Genentech/Roche’s Perjeta®.  While the Joint Stipulation confirms that the parties have entered into a settlement agreement, the terms of that settlement remain confidential and no details of any planned US launch of Poherdy® have been disclosed to date.

In the legal proceedings, Genentech and Roche had alleged infringement by Henlius and Organon of 24 US patents relating to pertuzumab, pharmaceutical compositions comprising pertuzumab, methods of treatment using pertuzumab and methods of manufacturing therapeutic antibodies like pertuzumab.  In response, Shanghai Henlius and Organon sought declarations of non-infringement and invalidity of the patents.

The litigation followed FDA acceptance of Henlius/Organon’s Biologics Licence Application for HLX11 in January 2025.  HLX11 received FDA approval, as Poherdy® in November 2025 and was designated as interchangeable to Perjeta®.  No other pertuzumab biosimilars have received US approval.

Henlius and Organon struck a licensing deal in June 2022 giving Organon exclusive global commercialisation rights to Henlius’ pertuzumab and denosumab biosimilars, “except for China; including Hong Kong, Macau and Taiwan”.

Biocad’s pertuzumab biosimilar, Pertuvia™, was approved in Russia in May 2025 and pertuzumab biosimilars have been approved in India (Enzene, Zydus and Intas).  R-Pharm and Sandoz/EirGenix have pertuzumab biosimilars in their pipelines.

On 22 December 2025, R-Pharm announced that it has presented its progress on two biosimilar products at the 29th Russian Oncology Congress: Persinthia®, biosimilar to Roche’s Perjeta® (pertuzumab), for the treatment of HER2-positive breast cancer; and Arcetux®, biosimilar to Eli Lilly/Merck KgGa’s Erbitux® (cetuximab), for treatment of head and neck tumours.  Both biosimilars have completed Phase III trials and R-Pharm expects they will gain registration in Russia in 2026.

Biocad already has Russian approval for a pertuzumab biosimilar.  Pertuzumab biosimilars have also been approved in at least the US (Shanghai Henlius) and India (Enzene, Zydus and Intas).

Roche has recently indicated that biosimilar competition to Perjeta® (pertuzumab) is a bigger concern than it previously anticipated.  Roche is also taking legal action in India to prevent biosimilar competition to Perjeta® from Zydus’ Sigrima® product, with the High Court of Delhi issuing an interlocutory judgment in July 2025.

Further pertuzumab biosimilars are under development – Sandoz and EirGenix have a commercialisation deal in place for EG1206A (November 2025) and received positive feedback from both the FDA and the European Medicines Agency, confirming that the product qualifies for an abbreviated development pathway allowing for the waiver of Phase III comparative efficacy trials.

In May 2023, Lupin and Enzene announced a strategic collaboration to launch Cetuxa® in India, as the first biosimilar cetuximab in that country.  In January 2018, Amgen disclosed at the JP Morgan Healthcare Conference that it was in the process of developing a cetuximab biosimilar.

On 15 December 2025, AstraZeneca announced that the FDA has approved the combination of Enhertu® (trastuzumab deruxtecan) with Roche’s Perjeta® (pertuzumab) for the 1st-line treatment of adult patients with unresectable or metastatic HER2-positive breast cancer.  This is the first new 1^st-line treatment approved in a decade for this indication.

Enhertu® has previously been approved as monotherapy for breast cancer including in Australia (October 2021), Japan (March 2023), China (July 2023), New Zealand (December 2023), USA (January 2025) and India (May 2025).  A biosimilar to Enhertu® is reportedly under development by Samsung Bioepis.

Roche has been fighting a rising tide of pertuzumab biosimilars including in the USA and India with other competitors on the horizon in China, Europe and Russia.