Generics Bulletin is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction

Biosimilars

Set Alert for Biosimilars

Alvotech’s Japanese Ustekinumab Nod Is ‘First For Global Markets’

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).

Biosimilars Approvals

Not In 2023 After All? FDA Turns Down Approval For Coherus’ On-Body Pegfilgrastim

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.”

Biosimilars Value-Added Medicines

Sandoz Prepares For European Natalizumab Launch As Approval Arrives

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.

Biosimilars Approvals

‘There Is Always Room For Improvement’: Celltrion Reflects On A Decade Of European Biosimilars

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.

Biosimilars Europe

Fresenius Kabi Gets Ready To Launch Europe’s First Tocilizumab Rival

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.

Biosimilars Approvals

BioFactura Completes Phase I For Late-To-Market Stelara Biosimilar

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.

Biosimilars Strategy

Biocon Gets A New Group CEO As Aflibercept Approval Arrives

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.

Executive Changes Leadership

Abbott To Take mAbxience Biosimilars To Emerging Markets From 2025

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.

Biosimilars Deals

Alvotech Gets A Fresh Date For Adalimumab In US

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.

Biosimilars United States

Biosimilar Clinical Trials: How Can Regulators Determine Waiver Early In Development?

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.

Biosimilars Clinical Trials

Sandoz Looks To Join EU Trastuzumab Party With CHMP Thumbs Up

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.

Biosimilars Drug Review

Dr Reddy’s Is Latest Rumored Buyer For Biogen’s Biosimilars

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.

Deals M & A

From Interchangeability To Invisibility: FDA Wipes Designation From Biosimilar Labels

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.

Biosimilars Regulation

Novartis Shareholders Give Green Light To Sandoz Spinoff

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.

Strategy Generic Drugs

IGBA Welcomes Mexican Membership

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

Mexico Generic Drugs

Intas Rumored As Another Suitor For Biogen’s Biosimilars Business

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.

Deals M & A
See All
UsernamePublicRestriction

Register