Biosimilars

Ahead of the Global Generics & Biosimilars Awards, which are this year being held on Wednesday 25 October at the Hotel Porta Fira in Barcelona, we reveal our final shortlist of entrants across all 14 categories.

As biosimilars to Stelara (ustekinumab) continue to advance in global markets, Rani Therapeutics has made progress for its proposed RT-111 orally administered ustekinumab biosimilar.

While it currently sits in fourth place, Amneal’s co-CEO Chirag Patel has laid out ambitions for the firm to become the number one supplier of affordable medicines in the US.

As the US Food and Drug Administration re-evaluates the need for comparative clinical efficacy studies for biosimilars, Leah Christl – executive director for global biosimilars regulatory affairs and R&D policy at Amgen, and former associate director for therapeutic biologics at the FDA – suggests that any reforms should be careful not to tie the agency’s hands in evaluating biosimilarity.

Following the formation of their partnership nearly five years ago, Alvotech and Fuji have together welcomed approval in Japan for Alvotech’s biosimilar to Stelara (ustekinumab).

Coherus BioSciences says that it will work closely with the US Food and Drug Administration and the unnamed third-party filler to obtain approval for its proposed version of Neulasta Onpro on-body injector “as quickly as possible.”

As it announced the formal European Commission approval of its partnered Polpharma Biologics-developed Tyruko natalizumab biosimilar to Tysabri, Sandoz offered Generics Bulletin a timeframe for its expected launch in Europe.

Marking a decade since Celltrion’s Remsima version of infliximab became the first monoclonal antibody biosimilar approved in Europe, Kevin Byoung Seo Choi, senior vice president and head of the marketing division at Celltrion Healthcare, talks to Generics Bulletin about the firm’s progress so far and the “room for improvement” that the company perceives in areas such as regulation, market access and pricing, supply chain and procurement – as well as what the future holds for the Korean biosimilars giant.

Fresenius Kabi has celebrated the approval of Europe’s first tocilizumab biosimilar. The rival to RoActemra is expected to be launched later this year under a settlement agreement with originator Genentech.

BioFactura has completed a successful Phase I trial of its Stelara (ustekinumab) biosimilar BFI-751, which is expected to file in developed markets in 2026.

Biocon has named Peter Bains as its new group CEO, as the firm’s Biocon Biologics business confirmed that its aflibercept biosimilar to Eylea had become the first to receive a formal European approval.

European biosimilars specialist mAbxience will hand several of its biosimilars over to the global commercialization expertise of Abbott under a new agreement signed between the firms.

Alvotech has revealed a US FDA goal date of 24 February 2024 for its refiled AVT02 proposed high-concentration interchangeable adalimumab biosimilar rival to Humira, as the firm provided further details of the resubmission – including an expected facility reinspection.

The evidence is growing that comparative efficacy trials may not be necessary for all biosimilars, but regulators said they need a standard for sponsors to meet in order to waive them.

Sandoz looks to be in line for an EU-wide approval for its trastuzumab biosimilar during 2023, with the backing of the EMA’s Committee for Medicinal Products for Human Use.

With Biogen having put its biosimilars interests on the market, multiple bidders appear to be interested in the business. Dr Reddy’s has become the latest firm to be named in media reports as vying for a deal.