Biosimilars

Sandoz snatched commercialization rights to Lupin’s ranibizumab biosimilar across multiple global markets, while also taking steps to decarbonize its operations in Europe.

Alongside biosimilars, Lupin sees injectable products as one of the key growth drivers in the US, as competition for two of its “material” drugs and proposed tariffs are looming over the firm.

Amgen sees potential regulatory shifts toward streamlined biosimilar approvals as favorable, citing its strength in developing high-quality products.

Kashiv BioSciences has struck a deal with MS Pharma to market its omalizumab biosimilar rival to Xolair in the MENA region.

US non-profit Civica has announced a partnership with Fresenius Kabi to supply a Stelara rival, revealing pricing details for its exclusive unbranded version of Kabi’s Otulfi biosimilar that will be available from the start of next year.

Sandoz has revealed plans to streamline more biosimilar trials amid evolving regulatory moves towards minimizing the need for comparative efficacy studies. The disclosure was just one of many pipeline and portfolio updates provided as the firm delivered positive first-half results.

Amgen continues to advance its intravenous biosimilar programs for key immuno-oncology agents, including its ABP 234 biosimilar to Keytruda and ABP 206 biosimilar to Opdivo, despite growing interest in subcutaneous formulations enabled by hyaluronidase technology.

While biosimilars have seen success in Europe, there are still plenty of areas in which policy improvements could solve problems for the market, according to a new Samsung Bioepis white paper. Adam Levysohn, the firm’s local head of commercial strategy, talks about the proposals.

Fresenius Kabi has picked up commercialization rights to Polpharma Biologics’ vedolizumab biosimilars in almost all markets. Still, the originator Takeda stands solid with no competition expected until at least 2032.

Arrotex has entered into a strategic partnership with Celltrion Healthcare Australia to launch two first-to-market biosimilar medicines in Australia. These biosimilars, which treat chronic inflammatory conditions, are now listed on the PBS and available through pharmacies.

Cipla’s partnered filgrastim biosimilar is expected to debut in the US in Q2 FY26 and the Indian firm expects an investment return ratio for its biosimilar engine “not too far” from that of a complex generic product amid an enabling regulatory environment.

With the looming spin-off on the horizon, Samsung Bioepis looks at planned product launches and geographic expansion to maintain its annual revenue growth.

The importance of generic and biosimilar medicines is being recognized by the UK government for the first time. But, as Medicines UK’s CEO Mark Samuels tells Generics Bulletin, companies are still facing multiple hurdles in the market.

Private equity firm BC Partners has revealed that it is in exclusive negotiations to acquire Servier’s French generics and biosimilars business Biogaran. But with France’s government having expressed opposition to the sale, could there be strings attached?

Roche expects biosimilars to Perjeta and Xolair by the end of 2026, marking a key inflection point for two of its major franchises. Shanghai Henlius Biotech leads development for pertuzumab, while Celltrion is positioned as the frontrunner for omalizumab.

Sandoz has made yet another major move to further bolster its booming biosimilars business, striking a $300m deal to acquire outright a French development and manufacturing facility from existing biosimilars partner Just-Evotec Biologics.

This article compiles all of the data from Generics Bulletin’s 2025 ranking of the Top 50 firms across the generics and biosimilars industry, including additional details of how the various financial figures stack up.

In the third instalment of this year’s Generics Bulletin Top 50, we reveal which firms have entered the ranking for the first time.

Denosumab, aflibercept and ustekinumab biosimilars received positive opinions from the EMA’s CHMP at its meeting in July, along with an Opsumit generic from Accord.

In the second instalment of Generics Bulletin’s Top 50 ranking for 2025, we see plenty of movement among our mid-table collection of companies.