Other Updates

At its April meeting, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for Aurobindo Pharma’s subsidiary CuraTeQ’s Dazublys® (150 mg powder for concentrate for solution for infusion), biosimilar to Roche’s Herceptin® (trastuzumab).  The biosimilar is indicated for HER2-positive metastatic and early breast cancers.  According to Aurobindo, European Commission approval is expected in July 2025.

The first trastuzumab biosimilar was approved in the EU in November 2017 and in the US in December 2017.

On 25 April 2025, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommended marketing approval for eight denosumab biosimilars.

Gedeon Richter’s Junod® and Yaxwer®, biosimilars to Amgen’s Prolia® and Xgeva® respectively, received positive opinions for all indications of the reference medicines.  The EMA had accepted Richter’s MAA for review in July 2024.  Gedeon Richter’s denosumab biosimilars are the first monoclonal antibodies in the company’s biosimilar portfolio.

Biocon Biologics’ Vevzuo® (reference: Xgeva®) and Denosumab BBL (brand name currently under approval) (reference: Prolia®) were also recommended by CHMP.  The European sponsor for the products is Biosimilar Collaborations Ireland Limited, an indirect wholly owned subsidiary of Biocon Biologics.

Positive recommendations were also given to mAbxience’s Izamby® and Zentiva’s Zadenvi®, both biosimilars to Prolia®.

To date, there have been three sponsors with denosumab biosimilars approved in Europe: Celltrion’s Stoboclo®/Ozenvelt® (February 2025), Samsung Bioepis’ Obodence™ and Xbryk™ (February 2025), and Sandoz’s Wyost® and Jubbonti® (May 2024).  Accord Healthcare’s Jubereq® and Osvyrti® received CHMP positive opinions in March 2025 and the EMA has accepted MAAs for a number of other denosumab biosimilars including for STADA/Alvotech (AVT03, October 2024), Teva (TVB-009P, October 2024), Fresenius Kabi (FKS518, July 2024), and Shanghai Henlius/Organon (HLX14, May 2024).

On 24 April 2025, Samsung Bioepis published its ninth quarterly US Biosimilar Market Report, which has been released every quarter since April 2023.  The report details average sales price (ASP) and wholesale acquisition cost (WAC) information for commercially available biosimilars in the US.

The Q2/2025 edition reports that, as of March 2025, the FDA has approved a total of 73 biosimilars across 19 unique biological molecules, with 48 of those having launched in the US market.  Of note, in Q1/2025, six new ustekinumab biosimilars were launched in the US: Amgen’s Wezlana® (Jan 2025), Alvotech/Teva’s Selarsdi® (Feb 2025), Samsung Bioepis/Sandoz’s Pyzchiva® (Feb 2025), Biocon’s Yesintek (Feb 2025), Formycon/Fresenius Kabi’s Otulfi® (Mar 2025) and Celltrion’s Steqeyma® (Mar 2025).  According to Samsung Bioepis’ Report, ustekinumab biosimilar entrants provided steep WAC discounts of over 80%.  In comparison, Amgen’s Pavblu®, the only aflibercept biosimilar available in the US at the time of the Report, launched with WAC 12% lower than that of Regeneron’s Eylea®.

The Report also outlines reviews being undertaking by US and EU regulatory agencies for the purpose of streamlining biosimilar development: in particular, the EMA’s April 2025 reflection paper considering the possible waiver of comparative efficacy study requirements for biosimilars and the FDA’s guidance on biosimilar interchangeability.

On 24 April 2024, Halozyme Therapeutics announced that it has sued MSD (known as Merck in the US and Canada) for patent infringement in the US District Court for the District of New Jersey.  Halozyme is alleging that MSD/Merck’s subcutaneous formulation of Keytruda® (pembrolizumab) infringes 15 patents owned by Halozyme in relation to MDASE subcutaneous delivery technology.

Halozyme’s complaint states that the patents “arise out of Halozyme’s extensive research” regarding “modifications to a human hyaluronidase, known as PH20” which, amongst other things “allows for rapid subcutaneous administration of therapeutic drugs”.  Halozyme alleges that MSD’s SC Keytruda® includes berahyaluronidase alfa, a modified PH20 which “includes the amino acid modifications … covered by the asserted patents”.

Halozyme is seeking damages and an injunction preventing the manufacture, sale and import of SC Keytruda® in the US.  MSD/Merck is yet to file its defence.

The lawsuit follows reports in March 2025 that Halozyme had offered MSD/Merck an opportunity to licence its MDASE patents.  At the time, a spokesperson from MSD/Merck said the enzyme used in SC Keytruda® was “developed independently” from Halozyme and that MSD/Merck “strongly believe” that any Halozyme patents that attempt to cover the enzyme variant are invalid.

MSD/Merck has filed petitions for post-grant review with the US Patent Trial and Appeal Board challenging the validity of ten of Halozyme’s US patents, eight of which are asserted in the litigation.  The petitions, which are currently pending, were filed between November 2024 and April 2025 in relation to: US 11952600, US 12018298, US 12152262, US 12123035, US 12110520, US 12054758, US 12060590, US 12049652, US 12104185 and US 12037618.

In November 2024, MSD revealed positive topline results from its Phase 3 trial evaluating SC pembrolizumab (MK-3475A), together with Alteogen’s berahyaluronidase alfa, administered with chemotherapy.  The SC pembrolizumab demonstrated noninferior pharmacokinetics compared to intravenous (IV) Keytruda® (pembrolizumab) in combination with chemotherapy, in adults with metastatic non-small cell lung cancer (NSCLC).  At the JP Morgan Healthcare Conference in San Francisco on 14 January 2025, Merck/MSD announced an expected 2025 launch for SC Keytruda®.

On 24 April 2025, the outcomes of Australia’s Pharmaceutical Benefits Advisory Committee (PBAC) March 2025 meeting were published, including recommendations for the listing of three biosimilars on the Pharmaceutical Benefits Scheme (PBS).

Sandoz’s natalizumab biosimilar, Tyruko® (300 mg in 15 mL vial for intravenous infusion) has been recommended for PBS-listing under the same circumstances as Biogen’s Tysabri®.  Tyruko®, which was developed by Polpharma Biologics, is the first and only biosimilar natalizumab to have been approved in Australia (4 April 2025).

Celltrion’s Omlyclo® (omalizumab), biosimilar to Genentech/Novartis’ Xolair®, was recommended for PBS-listing (as 75 mg/0.5 mL and 150 mg/1 mL PFS) for the treatment of uncontrolled severe asthma, uncontrolled severe allergic asthma and severe chronic spontaneous urticaria.  The PBAC considered that “the application of biosimilar uptake drivers to Omlyclo® would be clinically appropriate and would not impact cost effectiveness”.  Such biosimilar uptake drivers include an Authority Required requirement for the inclusion of an administrative note across all Omlyclo® listings encouraging use of the biosimilar brand for treatment naïve patients.  Omlyclo® is the first, and currently only, omalizumab biosimilar approved in Australia (November 2024).

Samsung Bioepis’ Epyztek® (ustekinumab) is recommended for PBS-listing for the same indications as its reference biologic, J&J’s Stelara®, in three forms: 45 mg/0.5 mL in a 0.5 mg PFS for injection, 90 mg/1 mL PFS for injection and solution for IV infusion 130 mg in 26 mL.  As for Omlyclo®, PBAC considered that the application of biosimilar uptake drives to Epyztek® would be appropriate.  Epyztek® was the fourth ustekinumab biosimilar to be approved in Australia in October 2024, following Celltrion’s SteQeyma®/CT-P43 (September 2024) and Amgen’s Wezlana® (January 2024) and Ajemnye® (May 2024).  Australia’s PBAC recommended Wezlana® for PBS listing at its March 2024 meeting.

The UK’s National Institute for Health and Care Excellence has recommended NHS funding for Bristol Myers Squibb’s immunotherapy combination Opdivo® (nivolumab) and Yervoy® (ipilimumab) as a first-line treatment for metastatic colorectal cancer patients who have high microsatellite instability (MSI-high) or mismatch repair deficiency (dMMR).

This follows recent approval of this combination for this indication in the US and Europe, while applications remain pending in Australia (TGA application filed in July 2024) and Japan (supplemental application filed in September 2024).

On 18 April 2025, Sanofi and Regeneron announced that Dupixent (dupilumab) received FDA approval as the first new targeted therapy in over a decade for chronic spontaneous urticaria (CSU).  The FDA had accepted Sanofi/Regeneron’s resubmitted supplemental Biologics Licence Application (sBLA) for Dupixent® (dupilumab) for the treatment of CSU in November 2024, with a target action date of 18 April 2025.

Dupixent is already approved for CSU in Japan, the United Arab Emirates, and Brazil.

On 18 April 2025, Regeneron announced that it received a complete response letter (CRL) from the US FDA regarding the supplemental Biologics Licence Application (sBLA) for Eylea HD® (aflibercept, 8mg injection) with extended dosing intervals (up to every 24 weeks) across all approved indications.

Eylea HD® is currently approved in the US with dosing intervals of every 8-16 weeks for nAMD and diabetic macular oedema (DME), and every 8-12 weeks for diabetic retinopathy (DR), following 3 initial monthly doses.  According to Regeneron, the CRL “did not identify any issues with the safety or efficacy of Eylea HD® in its approved indications and dosing regimens”.  Regeneron is “evaluating the FDA’s decision and will determine a path forward in due course.”

This news comes only a day after Regeneron’s sBLA for Eylea HD® for treatment of macular oedema following retinal vein occlusion (RVO), and for broadening the dosing schedule to include monthly dosing across approved indications, was accepted by the FDA for Priority Review.  The FDA’s target action date is 19 August 2025.

Eylea HD® (known as Eylea™ 8mg in Europe) was jointly developed by Bayer and Regeneron.  Regeneron holds the exclusive rights to both 2mg and 8mg Eylea® in the US, while Bayer holds those outside the US, where the companies equally share the profits from sales of the products.

Bayer filed an application with the European Medicines Agency (EMA) for approval of Eylea™ 8mg for the treatment of macular oedema following RVO earlier in April 2025.

On 16 April 2025, Shanghai-based CDMO, Chime Biologics, announced that it has entered a strategic cooperation agreement with Polpharma Biologics “to advance the end-to-end development and manufacture” of an undisclosed biosimilar product for the global market.  Under the agreement, Chime will provide Polpharma with biosimilar development support, including drug investigation and supply capabilities.

Polpharma currently manufactures biosimilars of natalizumab and ranibizumab.  Its Tyruko®, biosimilar to Biogen’s Tysabri® (natalizumab), is approved in Europe (September 2023) the US (August 2023) and Australia (April 2025), and is marketed and distributed by Sandoz under a global commercialisation agreement.

On 15 April 2025, Petrovax Pharm announced that it is launching its denosumab biosimilar (Forsedeno®) in the Russian market after the Russian Ministry of Health granted marketing authorisation.  This marks Russia’s first approved denosumab biosimilar to Amgen’s Prolia/Xgeva.

Petrovax Pharm acquired the rights to the denosumab biosimilar in Russia under an agreement with AryoGen Pharmed (part of CinnaGen Group).

In August 2024 Bio-Thera and Pharmapark entered a licence and supply agreement for a secukinumab biosimilar in Russia.