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Skojoy® received a positive recommendation for marketing approval from the CHMP in January 2025 but the application was withdrawn in April 2025.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 Usympro® (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 Usympro®/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.

On 30 January 2025, Amgen’s Pavblu® and Skojoy®, biosimilars to Regeneron/Bayer’s Eylea® (aflibercept), received positive recommendations for marketing approval from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP).  The two biosimilars are indicated for nAMD and visual impairment due to: macular oedema secondary to retinal vein occlusion (branch RVO or central RVO), diabetic macular oedema (DME) and myopic choroidal neovascularisation (myopic CNV).

Amgen’s Pavblu® was the first aflibercept biosimilar to be launched in the US in October 2024, following the Court of Appeals for the Federal Circuit’s denial of Regeneron’s application for an injunction against Amgen.

There are four aflibercept biosimilars already approved (but not yet launched) in the EU: Biocon’s Yesafili® (September 2023), Sandoz’s Afqlir® (November 2024), Samsung Bioepis/Biogen’s Opuviz™ (SB15) (November 2024) and Formycon/Klinge’s FYB203/Baiama®/Ahzantive® (January 2025).  Celltrion’s Eydenzelt®/CT-P42 (aflibercept) received a positive opinion at the CHMP’s December 2024 meeting, while Alvotech/Advanz Pharma and Altos Biologics have submitted MAA’s to the EMA for aflibercept biosimilars.

At its January 2025 meeting, the CHMP also provided good news for CuraTeQ, adopting a positive opinion for its Dyrupeg®, biosimilar to Amgen’s Neulasta® (pegfilgrastim) for the treatment of neutropenia.  This comes over 6 years after the approval of the first European pegfilgrastim biosimilar, Accord Healthcare’s Pelgraz®, in September 2018.

On 30 October 2024, Biocon Limited announced its financial results for Q3 2024, reporting that while its total consolidated revenue was flat (year on year), it experienced “robust performance” in its biosimilars business with growth of 19% (year on year).  Biocon attributes the biosimilar growth to an increase in market share in the US, expansion in Europe and 15 new launches in emerging markets.

Biocon reports that its oncology franchise, including Ogivri® (biosimilar trastuzumab, US launch in December 2019) and Fulphila® (biosimilar pegfilgrastim, US approval in June 2018), has experienced an increase in market share over the quarter (YoY), with the market share for Ogivri® increasing from 11% to 18% and that for Fulphila® increasing from 15% to 21%.  Biocon’s insulin products have also grown in market share with unbranded bGlargine and Semglee® (insulin glargine-yfgn) surpassing 15%.

Biosimilar highlights for the third quarter include the EMA’s validation of Biocon’s application for biosimilar denosumab and Biocon’s settlement and licence agreement in August 2024 for Yesintek™ (Bmab 1200), biosimilar to Janssen’s Stelara® (ustekinumab), permitting Biocon to launch in Europe, the UK, Canada and Japan following regulatory approval.  Biocon had previously entered a settlement agreement with Janssen in relation to ustekinumab in May 2024, allowing US launch in February 2025.  The FDA accepted Biocon’s BLA for Bmab 1200 for review under the 351(k) pathway in May 2024.

In emerging markets, Biocon specifically refers to launches of biosimilar bevacizumab and pegfilgrastim in Saudi Arabia and regulatory approvals for biosimilars of bevacizumab, etanercept, adalimumab, insulin aspart and rh-insulin in several countries in the Latin American, African and Middle East regions.

Biocon’s licensing and supply agreement with Tabuk Pharmaceutical for commercialisation of its GLP-1 products for diabetes and chronic weight management in certain Middle East countries and its exclusive distribution and supply agreement with a leading pharmaceutical company in Brazil (October 2024) for commercialisation of liraglutide (generic of Novo Nordisk’s Victoza®/Saxenda®) are also said to be Q3 2024 highlights.

On 23 August 2024, Indian-based Lupin announced that its Armlupeg®, biosimilar to Amgen’s Neulasta® (pegfilgrastim) received approval from Health Canada.  Armlupeg® is available in a pre-filled syringe of 6mg/0.6 ml.

This approval comes over 6 years after the first pegfilgrastim biosimilar was approved in Canada in June 2018 (Apotex’s Lapelga®).  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).

More recently, in February 2024, Coherus announced its US launch of Udenyca OnBody®, an on-body injector presentation of Undeyca® (pegfilgrastim-cbqv).

On 8 August 2024, Biocon Limited reported year on year consolidated revenue growth of 30% for Q2 2024, primarily as a result of a “one-time gain” from the strategic collaboration between Biocon and Eris Lifesciences announced in March 2024.  Although revenue for Biocon’s generics business decreased for the quarter, its biosimilars business delivered year-on-year growth of 11% compared with the same quarter last year.

Biosimilars highlights for the quarter are reported to include FDA-approval of Yesafili® (aflibercept) as the first interchangeable biosimilar to Regeneron’s Eylea® to be approved in the US (in May 2024, at the same time as Samsung Bioepis’ Opuviz® (aflibercept)), significant growth in US market share for Ogivri® (biosimilar trastuzumab, launched in December 2019) and Fulphila® (biosimilar pegfilgrastim, US approval in June 2018), EMA approval to manufacture biosimilar bevacizumab in Bengalaru (June 2024), a new non-exclusive agreement with a US pharmacy benefit manager for Hulio® (biosimilar adalimumab) and the addition of unbranded adalimumab to Costco’s member subscription program, and securing tenders in emerging markets and for Abevmy® (biosimilar bevacizumab) and Ogivri® (trastuzumab) in the UK.

In May 2024, Biocon reported that the US FDA had accepted for review Biocon’s BLA for Bmab 1200, biosimilar to Janssen’s Stelara® (ustekinumab).

Coherus Bioscience announced its US launch of Udenyca OnBody®, an on-body injector presentation of Undeyca® (pegfilgrastim-cbqv), biosimilar to Amgen’s Neulasta®.  Udenyca® is administered the day after chemotherapy to decrease the incidence of infection as manifested by febrile neutropenia.  The on-body injector utilises LTS Lohmann Therapie-Systeme AG’s wearable drug delivery platform. 

Udenyca OnBody® received FDA approval in December 2023. 

Coherus Biosciences announced it received FDA approval for Udenyca OnBody® the on-body injector presentation of Udenyca® (pegfilgrastim-cbqv), biosimilar to Amgen’s Neulasta®. Udenyca® is administered the day after chemotherapy to decrease the incidence of infection as manifested by febrile neutropenia.  Commercial availability is planned for Q1 2024.

Coherus resubmitted its Biologics License Application (BLA) supplement for Udenyca OnBody®  to the FDA in October 2023, following a satisfactory resolution of inspection findings at a third-party filler.  The resubmission comes after addressing the sole issue identified in the FDA’s Complete Response Letter it received on 21 September 2023.

CVS Caremark published its Performance Drug List for January 2024, notably removing Amgen’s Amjevita® (adalimumab), the first Humira® biosimilar launched in the US, and replacing it with Sandoz’s Hyrimoz® (adalimumab-adaz) as the preferred adalimumab product.

CVS will remove Regeneron’s Eylea® (aflibercept) and Genentech’s Lucentis® (ranibizumab), preferring either Biogen’s Byooviz® or Coherus’ Cimerli® (both ranibizumab biosimilars).  There are currently no FDA-approved aflibercept biosimilars, however on 31 October 2023 the FDA accepted Amgen’s BLA for ABP938, and on 29 August 2023 the FDA accepted Formycon’s BLA for FYB203.

CVS will de-list Sandoz’s Ziextenzo® (pegfilgrastim), biosimilar to Amgen’s Neulasta®, and prefer Amneal Bioscience’s Fylnetra® and Pfizer’s Nyvepria®.   CVS will also remove Amgen’s Kanjinti® and Pfizer’s Trazimera®, trastuzumab biosimilars to Genentech’s Herceptin®, preferring Teva’s Herzuma® or Biocon Biologics’ Ogivri®.