On 9 July 2026, PR Newswire reported that the FDA has approved Accord BioPharma’s Ennumo™, biosimilar to Amgen’s Neulasta® (pegfilgrastim), for all approved reference indications.

According to the announcement, Accord is now the only company in the US offering two distinct pegfilgrastim biosimilars to Amgen’s Neulasta®, Ennumo™ (pegfilgrastim-pccg) and Udenyca® (pegfilgrastim-cbqv).  Udenyca® was acquired by Intas Pharmaceuticals (Accord’s parent company) from Coherus Biosciences in August 2025.

There are a number of other pegfilgrastim biosimilars approved in the US, including Mylan/Biocon’s Fulphila® (approved June 2018, launched July 2018), Coherus/Accord’s Udenyca® (PFS approved November 2018, PFS launched January 2019; autoinjector approved March 2023, autoinjector launched May 2023; Udenyca OnBody® approved December 2023, launched February 2024), Sandoz’s Ziextenzo® (approved November 2019), Pfizer’s Nyvepria® (approved June 2020), Amneal/Kashiv’s Fylnetra™ (approved May 2022, launched May 2023), Fresenius’ Stimufend® (approved September 2022, launched February 2023) and Lupin’s Armlupeg™ (approved December 2025).

On 26 June 2026, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) announced the outcomes of its June 2026 meeting, including positive opinions for two biosimilars and recommended indication extensions for a number of biopharmaceuticals.

Ascend GmbH (a subsidiary of Alkem Laboratories) secured a CHMP positive opinion for “Denosumab Ascend”, biosimilar to Amgen’s Xgeva® (denosumab).  In November 2025, Alkem’s subsidiary, Enzene, received a CHMP positive opinion for Osqay®, biosimilar to Amgen’s Prolia® (denosumab).  Enzene and Theramex entered into an agreement in 2021 under which Enzene will supply Theramex with its denosumab biosimilar for commercialisation in Europe, the UK, Switzerland and Australia.  Alkem and Ascend are currently parties to BPCIA litigation commenced by Amgen in November 2025 following the filing of Alkem/Ascend’s BLA for biosimilar denosumab in the US.

The second biosimilar to be recommended by CHMP at its June 2026 meeting was Qilu Pharma’s Nylaspeg™, biosimilar to Amgen’s Neulasta® (pegfilgrastim).  The recommendation comes over 7 years after the approval of the first European pegfilgrastim biosimilar, Accord Healthcare’s Pelgraz®, in September 2018.

CHMP’s June 2026 positive opinions for extended indications include:

• Janssen’s Stelara® (ustekinumab) for the treatment of moderately to severely active ulcerative colitis in paediatric patients from the age of 2 years and older, who have had an inadequate response to, or were intolerant to either conventional therapy or a biologic.
• AstraZeneca/Daiichi Sankyo’s Datroway® (datopotamab deruxtecan) as a monotherapy, for the first-line treatment of adult patients with unresectable or metastatic triple-negative breast cancer (TNBC) who are not candidates for PD-1/PD-L1 inhibitor therapy; and
• Janssen’s Tecvayli® (teclistamab) in combination with daratumumab for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least one prior therapy.

On 9 January 2026, Aurobindo Pharma announced in a regulatory filing that its subsidiary, CuraTeQ Biologics, has received approval from Health Canada for Dyrupeg®, biosimilar to Amgen’s Neulasta® (pegfilgrastim).  In the same regulatory filing, CuraTeq also disclosed that it has three other biosimilar applications currently under review with Health Canada.

Dyrupeg® was approved in the EU in March 2025 following its positive recommendation from the EMA’s CHMP two months earlier.  In June 2025, Dyrupeg® also received marketing authorisation in the UK.

There are a number of other pegfilgrastim biosimilars approved in Canada, including Apotex’s Lapegla® (June 2018). Mylan/Biocon’s Fulphila® (June 2018), Accord Healthcare’s Pelgraz® (September 2018), and Nora Pharma’s Niopeg® (April 2024).

On 1 December 2025, Lupin announced that the US FDA has approved Armlupeg™, biosimilar to Amgen’s Neulasta® (pegfilgrastim) in 6 mg/0.6 mL pre-filled syringe (PFS) form.  Just days later, on 4 December 2025, Lupin also announced that it entered into an exclusive licensing agreement with Valorum Biologics for the US commercialisation of Armlupeg™.

Under the terms of the licence agreement, Valorum will be the responsible for commercialisation and distribution of Armlupeg™, while Lupin will be responsible for manufacturing and supply of the product and will receive an upfront licence fee and a royalty payment on net sales.

There are a number of other pegfilgrastim biosimilars approved in the US, including Biocon’s Fulphila® (June 2018), Coherus/Accord’s Udenyca® (November 2018), Sandoz’s Ziextenzo® (November 2019), Pfizer’s Nyvepria® (June 2020), Amneal/Kashiv’s Fylnetra™ (May 2022), and Fresenius’ Stimufend® (September 2022).

The US approval of Armlupeg™ follows approval by Health Canada in August 2024 for the same presentation.

On 6 August 2025, Intas Pharmaceuticals, and its global subsidiaries operating under the Accord brand, announced the successful acquisition of Udenyca®, biosimilar to Amgen’s Neulasta® (pegfilgrastim), from Coherus Biosciences.  The addition of Udenyca® expands Intas and Accord’s biosimilar portfolio, which already includes Accord’s other biosimilar pegfilgrastim, Pelgraz®.

The successful acquisition of Udenyca® follows announcement of the agreement for its sale in December 2024 under which Coherus would receive USD$483.4 million upfront, with up to USD$75 million in potential milestone payments based on net sales performance.

In March 2025, Coherus further announced that it will transfer approximately 50 employees to Intas Pharmaceuticals’ specialty unit, Accord BioPharma.  The move will reduce Coherus’ workforce by around 30%, leaving it with approximately 155 employees.

On 2 July 2025, Sunshine Biopharma announced that its wholly owned Canadian subsidiary, Nora Pharma, has launched Niopeg®, biosimilar to Amgen’s Neulasta® (pegfilgrastim) in Canada.  Niopeg® was approved by Health Canada in April 2024 in pre-filled syringe of 6mg/0.6 ml.

The first pegfilgrastim biosimilar approved in Canada was Apotex’s Lapegla® in June 2018.  Shortly after, Mylan/Biocon’s Fulphila® (pegfilgrastim) was approved in the US (June 2018) and Accord Healthcare’s Pelgraz (pegfilgrastim) was approved in the EU (September 2018).

On 2 July 2025, Navlin Daily reported that the Spanish Ministry of Health issued a tender for the sustainable supply of biologics and biosimilars under a two-year Framework Agreement worth €411 million coordinated by the Instituto Nacional de Gestión Sanitaria (INGESA).

According to the report, this second-phase agreement builds upon the initial framework launched in late 2022, which generated over €120 million in cost savings to date.  The new agreement is expected to deliver an additional €178 million in savings and will comprise 17 therapeutic categories covering biologics that have approved biosimilars.  The Framework Agreement includes the following biologics, among others: adalimumab, etanercept, infliximab, rituximab, trastuzumab, pegfilgrastim, bevacizumab, tocilizumab, natalizumab, eculizumab, ranibizumab and ustekinumab.

INGESA will select between 25 and 50 suppliers using an open procedure, with contracts awarded based on 70% price and 30% quality weighting.

On 24 June 2025, Biocon Biologics announced it has partnered with the National Cancer Society of Malaysia (NCSM), a non-for-profit organisation, to launch a Patient Assistance Program advocating for the accessibility and affordability of biosimilars.  Biocon intends to supply the NCSM with a range of biosimilars from its oncology portfolio, including trastuzumab, pegfilgrastim and bevacizumab.  The program will commence with provision of bTrastuzumab to cancer patients currently facing treatment delays due to budget constraints.

In the US, Biocon’s oncology franchise includes Ogivri® (biosimilar trastuzumab, launched in December 2019), Fulphila® (biosimilar pegfilgrastim, approved June 2018) and Jobevne™ (biosimilar bevacizumab, approved April 2025).

On 20 June 2025, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) published the outcome of its June meeting, with positive opinions for aflibercept biosimilars of STADA, Polpharma and Advanz Pharma, and Bio-Thera’s biosimilar ustekinumab.

STADA’s Afiveg®, Polpharma’s Eiyzey® and Vgenfli®, and Advanz Pharma’s Mynzepli®, biosimilars to Regeneron/Bayer’s Eylea® (aflibercept), were each recommended (as 40 mg/ml solution for injection in pre-filled syringes and vials) for treatment of nAMD and visual impairment due to macular oedema secondary to retinal vein occlusion/diabetic macular oedema (DME)/myopic choroidal neovascularisation.

There are currently seven aflibercept (2mg) biosimilars approved in Europe: Celltrion’s Eydenzelt® (February 2025), Biocon’s Yesafili® (September 2023), Sandoz’s Afqlir® (November 2024), Samsung Bioepis/Biogen’s Opuviz™ (SB15) (November 2024), Formycon/Klinge’s Baiama® and Ahzantive® (January 2025) and Amgen’s Pavblu® (April 2025).  Amgen’s Skojoy® received a positive recommendation for marketing approval from the CHMP in January 2025 but the application was withdrawn in April 2025.

Bio-Thera Solution’s Usymro® (BAT2206), biosimilar to J&J/Janssen’s Stelara® (ustekinumab) also received a positive CHMP opinion, for the treatment of plaque psoriasis, psoriatic arthritis and Crohn’s disease.  Bio-Thera and Gedeon Richter entered into a licence and commercialisation agreement for Usymro®/BAT2206 in October 2024, under which Bio-Thera is responsible for the development and manufacturing of the product while Richter has commercialisation rights for the EU, UK and Switzerland.  BAT2206 was approved in the US in May 2025 where it is to be commercialised by Hikma Pharmaceuticals under the name Starjemza®.

A sixth biosimilar recommended by the CHMP at its June meeting was Biocon’s Vivlipeg®, biosimilar to Amgen’s Neulasta® (pegfilgrastim), to reduce the duration of neutropenia and the incidence of febrile neutropenia after cytotoxic chemotherapy.  The recommendation comes over 6 years after the approval of the first European pegfilgrastim biosimilar, Accord Healthcare’s Pelgraz®, in September 2018.

On 10 March 2025, Coherus BioSciences reported its fourth quarter and full year financial results for 2024, and announced that it will transfer approximately 50 employees to Intas Pharmaceuticals’ specialty unit, Accord BioPharma.  The move will reduce Coherus’ workforce by around 30%, leaving it with approximately 155 employees.

The divestiture follows Coherus’ December 2024 agreement with Accord’s parent company, Intas Pharmaceuticals, for the sale of its pegfilgrastim (Udenyca®), biosimilar to Amgen’s Neulasta®, under which Coherus received USD$483.4 million upfront, with up to USD$75 million in potential milestone payments based on net sales performance.  With the Udenyca® divesture, Coherus has now fully transition away from biosimilars, refocusing on its immune-oncology pipeline.

The addition of Udenyca® to Accord’s portfolio follows a number of important milestones achieved by the company for its biosimilar pipeline in recent months.  In February 2025, Intas and Bio-Thera reached an exclusive commercialisation and licence agreement for golimumab (BAT2506), biosimilar to J&J’s Simponi® and Simponi Aria®, under which Accord will be responsible for commercialising the product in the US and Bio-Thera will retain responsibility for development, manufacturing and supply.

In December 2024, the European Commission granted marketing authorisation for Accord Healthcare’s Imuldosa®, biosimilar ustekinumab, for a range of immune medicated inflammatory diseases.  Imuldosa® was developed jointly by Dong-A Socio Holdings and Meiji Seika Pharma.  In July 2021, Dong-A ST signed a global out-licensing agreement with Intas Pharmaceuticals.  Imuldosa® will be launched in multiple regions, through Intas and its subsidiaries, including Accord Biopharma in the United States and Accord Healthcare in Europe, the UK, and Canada.