A Phase 3 study of BAT1806, a proposed biosimilar referencing Actemra/RoActemra (tocilizumab), has shown equivalent efficacy and a comparable safety profile in patients with moderate-to-severe rheumatoid arthritis.
Novartis subsidiary, Sandoz, says the US Supreme Court has denied its petition to review the Federal Circuit’s decision last summer in relation to Erelzi, its biosimilar of the Amgen reference medicine, Enbrel (etanercept), which is used to treat autoimmune...
The Medicines and Healthcare products Regulatory Agency (MHRA) has published final guidance on how the UK will license biosimilar products now it is outside of the European Union.
Roche witnessed a slight decrease in Q1 2021 pharmaceutical sales – a drop of 9% compared to the first three months of 2020 - as it faced continued biosimilars competition; the COVID-19 pandemic also played a role.
Efficiency in the biopharmaceutical space has never been more top-of-mind. The COVID-19 pandemic brought an unprecedented urgency to R&D and the key players delivered: Several groups produced a vaccine in record time. To maintain and improve on this...
A US court’s recent decision to find in favor of Sanofi and invalidate Amgen's broad antibody patent claims has biotech manufacturers concerned about how to preserve their IP.
Pfizer is selling a biologics manufacturing unit in the eastern city of Hangzhou to WuXi Biologics, despite the US pharma giant having ploughed US$350m into the site in 2016 to develop biosimilars.
Celltrion’s adalimumab biosimilar, Yuflyma (CT-P17) has been approved by the European Commission for the treatment of multiple chronic inflammatory diseases, including rheumatoid arthritis, psoriasis, Crohn’s disease, and ulcerative colitis.
The new EU Pharmaceutical Strategy, adopted today by the European Commission, is designed to improve and accelerate patients’ access to safe and affordable medicines and address unmet medical needs in the areas of antimicrobial resistance, cancer, and...
Accord Healthcare has announced the launch of a Herceptin biosimilar in the UK. Zercepac is the first monoclonal antibody (mAb) and fourth biosimilar launched by the company in Europe.
This month marks a major US milestone for biosimilar medicines as five years ago, September 2015, saw the first biosimilar made available to US patients – the Sandoz developed Zarxio (filgrastim-sndz).
Anti-competitive actions by companies hamper uptake of biosimilars, the US FDA suggests, and announces a series of actions that will be taken against them.
Celltrion receives EMA marketing authorisation for Remsima SC, the first subcutaneously-administered option for delivery of infliximab, a treatment for rheumatoid arthritis.
During this year’s Festival of Biologics conference, one track saw a focus on biosimilars that brought together experts from across the industry to map the future for such treatments in the EU and US.
iBio grants CC-Pharming exclusive license to commercialize rituximab in China, as well as a research license to bring its FastPharming technology to the country.
Dr Reddy’s Laboratories enters a $31m market with the launch of Versavo, a biosimilar of Roche’s Avastin in India, indicated for several types of cancer.
Revance Therapeutics says developing a Botox biosimilar is “challenging, but not impossible” in reply to AbbVie’s dismissal of the prospect of a copy of the blockbuster coming to market.
The US District Court for the District of New Jersey ruled in Amgen’s favor on the validity of the two patents on Enbrel and the methods for making it.
With US spending on biologics reaching $125.5bn in 2018, a new report looks at the level of savings that could potentially be made and contrasts the US with the European market.
Mundipharma partners with Prestige to commercialize and supply a biosimilar to Roche’s Herceptin, for patients with breast, gastric and gastroesophageal cancer.
Avastin biosimilar from Pfizer receives approval from the FDA for the treatment of five forms of cancers, increasing market competition for the originator drug.
Amgen’s biosimilars portfolio reaches a milestone after its Herceptin biosimilar, Kanjinti, developed in collaboration with Allergan, was approved by the US FDA.
Biosimilar approvals in the US have increased by 600% and with biologic patent expiration dates approaching, biosimilar applications are on the rise as well.
The US FDA has approved Genentech’s auto-injector formulation of Actemra, which the firm says offers an additional administration option for patients and caregivers.
Unlike the European system, manufacturing authorisation holders in Jordan must own or operate from a manufacturing facility to apply for biosimilar approval, says JFDA executive.
As an increasing number of biosimilar developers target the European market, lesser-known firms may explore alternative commercialisation strategies, says Iqvia executive.
Leaf Expression Systems’ technology enables the manufacture of proteins, vaccines and complex biomolecules without using animal-based products, says recently appointed chief executive.
The California Department of Insurance has sued AbbVie for allegedly providing monetary gifts to health-care providers for prescribing its biologic, Humira.
A Phase I clinical trial to examine the safety and pharmacokinetics of BAT1806, an Actemra biosimilar, is to be conducted by Chinese pharmaceutical company Bio-Thera.
Just days after the release of its Biosimilar Action Plan to encourage generic competition, the US FDA has approved another biosimilar product: Pfizer’s answer to Amgen’s Neupogen, ‘Nivestym’.
Major pharmaceutical firms Novartis, Roche, and Pfizer have reacted to the US FDA’s Biosimilar Action Plan, which aims to “strike a balance” between innovation and market competition.
