New Zealand’s drug funding agency, Pharmac, has opened for public consultation a provisional agreement with Roche to fund a package of Roche drugs, including subcutaneous formulations of biologics previously only funded as IV treatments.  The agreement includes the following biologics:

• Avastin® (bevacizumab) for ocular conditions only. This represents a rare example of Pharmac funding two suppliers’ brands of the same biologic.  Celltrion’s bevacizumab biosimilar, Vegzelma®, was awarded Principal Supply Status for all reference indications by Pharmac in February 2025.  However, the agreement with Celltrion specifically allowed other brands to be funded for ocular conditions only.
• Ocrevus® SC (ocrelizumab), alongside IV Ocrevus®. Most patients are expected to switch to Ocrevus® SC.  No ocrelizumab biosimilars have been submitted for approval in New Zealand to date.
• Phesgo® (pertuzumab and trastuzumab) for subcutaneous treatment of HER2-positive metastatic breast cancer. Roche’s Perjeta® (pertuzumab) and Celltrion’s Herzuma® (biosimilar trastuzumab) are already funded as separate IV infusions for people with HER2-positive metastatic breast cancer.  It is expected that most patients receiving these in combination will now receive Phesgo® as it can be administered faster than the IV infusions, providing the same treatment benefit with less time spent receiving treatment.
• Vabysmo® (faricimab) for diabetic macular oedema and wet age-related macular degeneration. Funding criteria will be the same as updated criteria for aflibercept (Regeneron’s Eylea®).  Criteria for funding ranibizumab are also being updated.
• Gazyva® (obinutuzumab) and MabThera® (rituximab) will have funding criteria updated. No MabThera® biosimilar is currently funded for rheumatoid arthritis to date due to Roche patent protection subsisting in New Zealand for that indication.  Sandoz’s biosimilar rituximab, Riximyo®, is funded for all other (off-patent) indications.

Submissions on the provisional agreement may be made until 5.00pm 8 October 2025 (NZ time).

On 22 September 2025, Enzene Biosciences announced the Indian launch of its biosimilar to Roche’s Perjeta® (pertuzumab).  According to Enzene, the biosimilar is being marketed in India by “multiple leading pharmaceutical companies”.  This includes Enzene’s parent company, Alkem Laboratories, which is marketing the biosimilar under the name Pertuza®, and Hetero Healthcare, which has announced the launch of the Enzene biosimilar under the name Perzea®.

Other pertuzumab biosimilars approved in India include Intas’ biosimilar (approved December 2024) and Zydus’ Sigrima™ (approved June 2024).  Sigrima™ is the subject of legal action in India by Roche, which is alleging infringement of patents IN268632 and IN464646.

Roche has recently indicated that biosimilar competition to Perjeta® is a bigger concern than it previously anticipated.  As well as the Indian proceedings against Zydus, Roche has also sued Shanghai Henlius and Organon in the US, alleging that their pertuzumab biosimilar, HLX11, infringes multiple US patents.

On 14 August 2025, Genentech and Hoffman-La Roche filed BPCIA litigation in the US District Court for the District of New Jersey alleging infringement of 24 US patents relating to their Perjeta® branded pertuzumab cancer treatment.  The allegations relate to Shanghai Henlius’ (in conjunction with Organon) application to the FDA for approval of its pertuzumab biosimilar, HLX11, which was accepted in January 2025.

The asserted patents cover pertuzumab, pharmaceutical compositions comprising pertuzumab, methods of treatment using pertuzumab, and methods of manufacturing therapeutic antibodies like pertuzumab and are US7862817, US865474, US9181346, US11414498, US11597776, US12110341, US7449184, US8404234, US10689457, US11655305, US11077189, US11638756, US11992529, US12128103, US10808037, US11078294, US12145997, US12173080, US9815904, US9969811, US12415998, US10662237, US10676710, and US12103975.

In June 2022, Shanghai Henlius entered into a licence agreement with Organon regarding HLX11 (and HLX14), under which Organon has exclusive global commercialisation rights to the biosimilars for all countries except China, Hong Kong, Macau and Taiwan.

This action comes less than a month after Roche acknowledged that biosimilar competition to Perjeta® was closer than it previously anticipated, and just over a quarter since Roche downplayed the potential threat from Henlius.  HLX11 is under also consideration for approval in Europe (March 2025) and China (December 2024).

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.

On 25 July 2025, the High Court of Delhi issued an interlocutory judgment in ongoing patent infringement litigation brought by Roche to prevent Zydus from launching Sigrima®, biosimilar to Roche’s Perjeta® (pertuzumab), in India.

One of Roche’s patents in suit, IN464646, claims a process for making a composition comprising pertuzumab.  Roche had sought disclosure, on a confidential basis, of Zydus’ manufacturing process for Sigrima®.  Roche invoked section 104A of India’s Patents Act 1970, under which a defendant may carry the burden of proving non-infringement of a patent that claims a process for producing a product, if the defendant’s product is shown to be “identical” to one produced by the patented process.

The Court found that Roche had not proved that Sigrima® was “identical” to the product of the patented process.  Roche’s only evidence was the use by Zydus of Perjeta® as the reference drug for Sigrima®.  This was only sufficient to prove that Sigrima® met the regulatory guidelines for biosimilarity but not that it was “identical” to Perjeta®.  It remains open to Roche to prove the products are identical by other means in the substantive trial.

Zydus is also facing infringement proceedings in India alleging that Zydus’s ZRCr-4276, biosimilar nivolumab, infringes BMS’ patent IN340060, which protects Opdivo® (nivolumab, branded as Opdyta® in India).

Roche’s 2025 second-quarter earnings call included disclosure that it now expects biosimilar competition to Perjeta® (pertuzumab) and Xolair® (omalizumab) in 2026, sooner than previously anticipated.

In its previous quarterly earnings call in April 2025, Roche had said that it did not expect competition to Perjeta® until late 2027.  The biosimilar expected to provide the first serious competition remains Henlius/Organon’s HLX11, which is being considered for approval in Europe, the US, and China.  Organon’s own earnings call is scheduled for 5 August 2025.  Other pertuzumab biosimilars have been approved in India (Zydus and Intas) and Russia (Biocad).

Celltrion’s Omlyclo® (omalizumab) is already approved in the EU (May 2024), Korea (June 2024), Australia (November 2024), Canada (December 2024), the US (March 2025) and New Zealand (April 2025).  It has been the subject of legal disputes in at least the UK and Europe.

The results of a phase I study published in Annals of Medicine is said to have established biosimilarity between Beijing SL Pharmaceuticals’ pertuzumab biosimilar, KM118, and the reference product, Roche’s Perjeta®.

Roche has previously claimed it is unconcerned about biosimilar pertuzumab products despite pertuzumab biosimilars being considered for approval in China, Europe and the USA (all by Henlius), and approved in India (Zydus and Intas) and Russia (Biocad).

On 28 May 2025, Russia’s GxP News reported that the Russian Ministry of Health approved Russian biotechnology company Biocad’s Pertuvia™, biosimilar to Roche’s Perjeta® (pertuzumab), making it the country’s first domestic biosimilar pertuzumab approved for HER2-positive breast cancer.

This approval comes a month after Roche stated that it did not expect its Perjeta® to face biosimilar competition from Henlius’ HLX11 (pertuzumab) until late 2027.  HLX11 is currently under consideration by regulators in the EU, US and China.

On 30 April 2025, Roche announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending an update to the European Union (EU) label for Phesgo® to allow administration outside of a clinical setting, such as in a person’s home, by a healthcare professional.  Phesgo® is a subcutaneous fixed-dose combination of Perjeta® (pertuzumab) and Herceptin® (trastuzumab), used to treat human epidermal growth factor receptor 2 (HER2)-positive breast cancer.

Earlier this month, in its 2025 first quarter earnings call, Roche described its biosimilar exposure for its Perjeta® (pertuzumab) as “relatively limited” and “not a threat that we’re super worried about right now,” considering the lack of potential competitors in late-stage development or filing.  Roche believes that the most-advanced pertuzumab biosimilar, Henlius’ HLX11, is unlikely to enter the market until at least late 2027.

HLX11 is currently under consideration for regulatory approval in the EU (March 2025), US (February 2025) and China (December 2024).  In June 2022, Henlius entered into a licence agreement with Organon regarding HLX11 (and HLX14), under which Organon has exclusive global commercialisation rights to the biosimilars for all countries except China, Hong Kong, Macau and Taiwan.

On 28 March 2025, Shanghai Henlius Biotech, Inc. and Organon announced that the European Medicines Agency (EMA) has validated their marketing authorisation application (MAA) for HLX11, biosimilar to Roche’s Perjeta® (pertuzumab).

Henlius/Organon have previously had applications for HLX11 accepted by the US FDA (February 2025) and China’s Center for Drug Evaluation of the National Medical Products Administration (December 2024).

In June 2022, Henlius entered into a licence agreement with Organon regarding HLX11 (and HLX14), under which Organon has exclusive global commercialisation rights to the biosimilars for all countries except China, Hong Kong, Macau and Taiwan.

Shanghai Henlius Biotech announced on 2 February 2025 that the US FDA has accepted its Biologics Licence Application (BLA) for HLX11, biosimilar to Roche’s Perjeta® (pertuzumab).

The US acceptance of Henlius’ BLA follows the December 2024 acceptance of its NDA for HLX11 by China’s Center for Drug Evaluation of the National Medical Products Administration.

In June 2022, Shanghai Henlius entered into a licence agreement with Organon regarding HLX11 (and HLX14), under which Organon has exclusive global commercialisation rights to the biosimilars for all countries except China, Hong Kong, Macau and Taiwan.