Biosimilars are a hot topic for biopharmas with differing regulations, ever changing approval mechanisms and looming patent expiries ensuring they are set to be a continuing subject of debate and discussion.
17-Jan-2017 - The US FDA expects biosimilar developers to provide data from switching studies to demonstrate interchangeability with a reference biologic in draft guidance published today.
13-Jan-2017 - 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.
11-Jan-2017 - The US FDA will decide whether to approve Biocon and Mylan’s version of the Roche breast cancer drug Herceptin by the beginning of September.
11-Jan-2017 - Celltrion deal and multi-million Euro German plant will make it a major second and third wave biosimilars player says Teva.
06-Jan-2017 - 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.
04-Jan-2017 - The US FDA has published final guidance on the development and use of clinical pharmacology data for drugmakers to demonstrate biosimilarity.
23-Dec-2016 - Over 30 companies are looking to compete against Abbvie in the adalimumab space. Can you find them all in our word search?
20-Dec-2016 - With four biosimilars now approved in the US, the sector is growing in confidence says a BMI Research analyst.
25-Nov-2016 - 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.
15-Nov-2016 - Manufacturing quality is key for biosimilar success says Pfenex, as the US FDA continues to increase its regulatory oversight.
11-Nov-2016 - 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.
09-Nov-2016 - 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.
08-Nov-2016 - A Herceptin (trastuzumab) biosimilar developed by Mylan and Biocon has been submitted to the US FDA.
04-Nov-2016 - 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.
04-Nov-2016 - Germany’s Merck has refused to comment on rumours it is looking to sell its biosimilars business, but what would a hypothetical buyer actually get?
01-Nov-2016 - Amgen has indicated it will not launch its approved biosimilar of Humira (adalimumab) until litigation battles with AbbVie are settled.
21-Oct-2016 - 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?
18-Oct-2016 - 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.
18-Oct-2016 - Pfizer’s Inflectra will become the first monoclonal antibody biosimilar available in the US when it is launched next month.
12-Oct-2016 - 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.
11-Oct-2016 - Teva has partnered with Celltrion to commercialise versions of Roche’s Herceptin and Rituxan, helping fill a gap in its second wave biosimilars pipeline.
04-Oct-2016 - The EMA will assess a version of Roche’s breast cancer drug Herceptin (trastuzumab), the fifth biosimilar candidate submitted for review by Samsung Bioepis.
28-Sep-2016 - 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?
28-Sep-2016 - Shire has reinforced its focus on rare diseases by exiting Baxalta's Humira and Enbrel biosimilar programmes with Momenta and Coherus.
26-Sep-2016 - 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.