Business

Harrow is taking aim at launching new partner Samsung Bioepis’ Byooviz biosimilar to Lucentis in 2026.

Fresenius Kabi’s IV drugs and fluids Pharma division rebounded in Q2, led by strong US and European volumes, especially in infusion therapies. Biopharma revenue rose by 26% to €190m, up one-third in constant currencies, driven by tocilizumab biosimilar ramp-up in Europe and the US.

Building on its decade-old plasma division in India, Intas and its subsidiary Accord signed an agreement to acquire one of Europe's largest plasma fractionators Prothya Biosolutions.

Gedeon Richter’s management discussed timelines for two key biosimilars during the firm’s first-half earnings call, while also revealing how the firm’s General Medicines division had suffered setbacks in the three months to June 30.

Viatris is conducting a company-wide strategic review to boost long-term competitiveness, targeting cost savings and a shift to complex, high-margin products. CEO Scott Smith says it’s timely after four divestitures. An update is due in the Q3 2025 earnings call in November.

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

Hikma is seeing increased US demand for its generic Victoza (liraglutide) after the end of semaglutide compounding lifted prices for Novo Nordisk’s Ozempic and Wegovy. Meanwhile, the company is not for now pursuing semaglutide generics in the US or EU due to patent protection, but is targeting MENA.

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.

Viatris and Amphastar are expanding their complex generic portfolios with the planned launches of FDA-approved versions of Vifor Pharma/Daiichi Sankyo’s Venofer (iron sucrose). The FDA’s database also show Sandoz holds an approval for generic Venofer, though it has not disclosed launch plans.

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

As Amneal reports another solid quarterly performance, with refinanced debt and adjusted financial guidance for the year, will Trump’s “chaotic” tariffs shake it all up?

A Duke-Margolis working group is developing ideas to enable non-profit firms to seek US FDA approval for new indications for off-patent medicines. The former acting commissioner thinks citizen petitions might be the fastest route.

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.

In our latest roundup of off-patent industry appointments, we see management changes at UK liquids specialist Rosemont, a push into biosimilars from Korea’s Daewoong, and fresh appointments at firms including Meitheal, Celltrion, Accord, Alvotech, Civica and Centrient.

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.

Aurobindo is confident its planned Lannett acquisition will pass US FTC scrutiny after an attempt to acquire Sandoz assets was called off in 2020 post a delay in approval. The deal could widen Aurobindo’s US manufacturing presence at a time when its US Q1 revenue saw a year-on-year decline.

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.