Biocon has been awarded a three-year contract to supply recombinant human insulin formulations made at its Malaysian facility to the country’s Ministry of Health.
Johnson & Johnson has predicted a 10-15% erosion in sales of Remicade (infliximab) in 2017 following Pfizer’s “at-risk biosimilar launch of Inflectra.”
A clear interchangeability pathway is essential for the US biosimilar market say developers as they begin reviewing the much-welcomed draft FDA guidance.
A UK judge says a vexatious litigation strategy is staving off Humira biosimilars, but AbbVie is “playing by the rules and incurring the costs of doing so,” according to an IP lawyer.
The US FDA expects biosimilar developers to provide data from switching studies to demonstrate interchangeability with a reference biologic in draft guidance published today.
US FDA sticks with four-letter random suffix for biosimilar names
Pfizer and industry groups have criticised the US FDA over the randomness of a four-letter suffix demanded in the nonproprietary names of biological products.
Teva aiming to be major second and third wave biosimilars company
Trump’s presidency could favour US biosimilars in 2017, but the sector will continue to be hampered by a lack of interchangeability guidance and ongoing litigation, say experts.
Celltrion is confident that 2017 will bring European approval and a US filing for Truxima, after achieving regulatory success for the Rituxan biosimilar in Korea.
Mylan has struck a deal to commercialise a version of Roche’s Mabthera in Europe made by Polish biotech Mabion using a 2,500L disposable bioreactor system.
The rejection of a petition against a Humira formulation patent is problematic for Coherus but may not affect other adalimumab biosimilar developers, an analyst says.
Biocon says it is well-positioned to up production of its Lantus biosimilar after the insulin glargine – co-developed with Mylan – was accepted for review in the EU.
Terms such as ‘copycats’ and ‘knock-offs’ are inaccurate and misleading, say drugmakers. We ask therefore how industry and the media should refer to biosimilar products?
A two year-long Phase IV study has shown Celltrion’s infliximab biosimilar is not inferior to its originator Remicade, but a physician group still urges caution when switching.
Long-awaited interchangeability guidance will strengthen the public’s confidence in biosimilars, but is likely to only affect 20% of all biological products, MedImmune and Biocon said at CPhI.
Teva has partnered with Celltrion to commercialise versions of Roche’s Herceptin and Rituxan, helping fill a gap in its second wave biosimilars pipeline.
The EMA will assess a version of Roche’s breast cancer drug Herceptin (trastuzumab), the fifth biosimilar candidate submitted for review by Samsung Bioepis.
Biosimilar makers have been vocal about product names not differentiating from their reference biologics, so why does the newly-approved Humira copy appear to reference its sponsor, Amgen?
Amid ongoing patent litigation, the FDA has approved Amgen’s Amjevita: the first US biosimilar version of AbbVie’s top selling rheumatoid arthritis biologic Humira.
J&J cannot stop Inflectra arriving in the US in October but warns Pfizer of the risk of launching it while the patent surrounding Remicade’s manufacture remains unresolved.
An invalidated Remicade patent has paved the way for Pfizer to launch Inflectra in October, but legal battles with J&J are far from over says an IP lawyer.
Asterias Biotherapeutics has selected Cognate BioServices for the process development and manufacture of its autologous dendritic cell vaccine candidate, AST-VAC1.
Lucentis biosimilar developer Formycon saw its share price jump 16% days after Pfizer abandoned efforts to create a rival version of Roche's blockbuster eye drug.
Highlighting indications approved through extrapolation and manufacturing information in drug labels are attempts to raise doubts over the safety of biosimilars, according to Sandoz.
Alexion has strengthened its Soliris (eculizumab) manufacturing IP and is developing a longer-acting C5 antibody ahead of potential biosimilar competition.
The EMA has said it will assess Samsung Bioepis’ version of Humira (adalimumab), which is the third biosimilar the (currently) London-based agency has accepted for review.
Pfizer has struck a strategic partnership with GE Healthcare to construct and equip a biomanufacturing centre focused on producing biosimilars for China.
The UK biosimilars industry has urged the Government to push for a single marketing authorisation in its upcoming negotiations with the EU, following today’s shock Brexit result.
The non-proprietary naming debate is “almost a little comical” says Sandoz, which argues a proposed four-letter suffix adds little to aid post-marketing surveillance of biological products.
Novartis will continue investing in its manufacturing network to support a biologics pipeline which includes five new biosimilars it expects to launch by 2020.
As part of a cost-savings restructure, Epirus is selling the assets from its $14m acquisition of Bioceros last September to its biosimilars partner Polpharma.
