Biosimilars

Alvotech has followed its European filing for a biosimilar to Regeneron’s Eylea (aflibercept) 2mg with acceptance for review from the US Food and Drug Administration for its AVT06 candidate.

While quarterly revenues show ups and downs in each region, Lupin is set on continued growth, with a touch of complexity and innovation – including shifting its thinking on the attractiveness of biosimilars.

Unleashing a trio of major announcements, Formycon has indicated a gloomy outlook for US Stelara biosimilar pricing; revealed plans to pause commercialization of its Sandoz-partnered US Cimerli rival to Lucentis amid discounting from rivals; and set out ambitious plans to win FDA approval for its proposed Keytruda biosimilar without any Phase III data.

In its latest draft standard contract for 2025/26, the National Health Service in England has proposed enhanced prescribing requirements “in recognition of the increasing importance of biosimilars in the provision of biological medicines.”

Samsung Bioepis is only the second firm to receive a US FDA endorsement for its denosumab biosimilars, with the nod coming at the same time as formal European Commission approval. But plenty more firms are waiting in line with their own rivals to Prolia and Xgeva.

Sanofi has bolstered its insulin offerings by bagging the first US FDA approval for a rapid-acting insulin aspart biosimilar, leaving several would-be sponsors in its wake.

While biosimilars updates were thin on the ground as Biogen reported its full-year results, the segment nevertheless reported growth in 2024. Meanwhile, the firm also offered some comments on how it saw generic and biosimilar competition to its Tecfidera and Tysabri multiple sclerosis brands playing out this year.

Discussing a new report highlighting the lack of US biosimilar competition on the cards for the majority of biologics losing exclusivity in the next ten years, the AAM’s Access! 2025 conference heard that the “sobering” findings should act as a “wake-up call for stakeholders.”

Biocon Biologics’ management shared updates regarding their facilities, expansion, and fast upcoming ustekinumab biosimilar launch in the US. Also, Biocon made a final acquisition payment to Viatris, while increasing its stake in the biosimilars business.

Having recently acquired Coherus’ biosimilar pegfilgrastim franchise in the US and welcomed FDA approval for its partnered ustekinumab biosimilar, Accord Biopharma is again spending big to flesh out its US biosimilar pipeline.

Bio-Thera Solutions has taken the next step towards launching competition to Johnson & Johnon’s Simponi blockbuster, filing its Stada-partnered BAT2506 golimumab candidate with Europe’s regulatory body following successful Phase III comparison data.

Speaking during its financial Q3 earnings call, Sun Pharma’s management has again pooh-poohed any idea of jumping into biosimilars in the near future, while providing updates on its trio of stricken Indian manufacturing facilities.

Fresh from filing its proposed biosimilar to Perjeta with the US FDA, Henlius has brought in Dr Reddy’s Laboratories as its US and European commercial partner for its proposed biosimilar to Darzalex, which has already succeeded in Phase I trials.

Amgen’s biosimilar sales grew by 16% last year, and with multiple candidates either due to launch or in the clinic, the firm is showing no signs of slowing down on its aspirations.

Organon is one step closer to introducing US biosimilar competition to Roche’s Perjeta blockbuster after partner Shanghai Henlius Biotech saw its application accepted for review by the US FDA. Roche meanwhile has spoken about how it expects to defend its loss of exclusivity, beginning potentially in 2026.

In its first meeting of 2025, the EMA’s CHMP issued positive opinions recommending marketing authorizations for Eylea and Neulasta biosimilars from Amgen and Aurobindo, as well as a Revolade generic from Accord.

Celltrion has become the third biosimilar sponsor to garner US FDA approval for a tocilizumab biosimilar rival to Actemra, preparing to enter a market that already includes versions from Fresenius and Biogen – albeit with uptake still low.

J&J’s fourth-quarter and full-year results have confirmed the decline for Stelara that had already begun to be seen late last year. And with US biosimilars now set to take a slice of the ustekinumab market following the launch of multiple European rivals last year, for the originator the only way is down.

Kashiv Biosciences has followed on swiftly from positive noises from Dr Reddy’s Laboratories, disclosing that its proposed biosimilar to the hard-to-manufacture costimulation modulator Orencia was a success in Phase I trials.

Alvotech and Teva have celebrated a first in the US with the FDA’s acceptance of a filing for their partnered AVT05 golimumab biosimilar rival to Simponi and Simponi Aria.