Biosimilars

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.

Amid continuing stakeholder confusion over the meaning and significance of the US FDA’s interchangeability designation for biosimilars, the agency has now recommended omitting altogether details of interchangeability from biosimilar labels.

At an extraordinary general meeting held earlier today, Novartis shareholders gave the go-ahead for the spinoff of the Sandoz generics and biosimilars business, paving the way for a formal separation on 4 October.

The IGBA has welcomed Mexican pharmaceutical industry association ANAFAM as an associate member.

Reports have named Intas as another possible buyer for Biogen’s biosimilars business, following earlier rumors that Samsung Bioepis could be interested in a deal. Generics Bulletin spoke to both Intas and Biogen for their reaction.