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-Feb-2017 - Biocon’s biomanufacturing facilities in India will need a “meaningful capacity expansion” to cope with long-term global biosimilar demand, the firm says.
15-Feb-2017 - Industry group the Biosimilars Forum has welcomed President Trump’s pick of Representative Tom Price as Secretary of Health and Human Services.
10-Feb-2017 - Aurobindo’s first biomanufacturing facility will be commissioned this year, the firm said after adding four candidates to its biosimilar pipeline.
01-Feb-2017 - Sandoz withdrew its pegfilgrastim biosimilar application before responding to concerns about the lack of cGMP accreditation at the candidate’s manufacturing site, the EMA says.
31-Jan-2017 - The EMA has recommended approval of two versions of AbbVie’s bestselling biologic Humira (adalimumab), both made by Amgen.
31-Jan-2017 - The EDQM and EMA aim to clarify how European Pharmacopoeia (Ph. Eur) monographs apply to biosimilars at an event next week.
27-Jan-2017 - Capacity upgrades and US FDA discussions delayed the filing of Sandoz’ Humira biosimilar, the company has confirmed.
26-Jan-2017 - 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.
25-Jan-2017 - Johnson & Johnson has predicted a 10-15% erosion in sales of Remicade (infliximab) in 2017 following Pfizer’s “at-risk biosimilar launch of Inflectra.”
20-Jan-2017 - The EMA and US FDA have agreed to review a candidate Humira (adalimumab) biosimilar developed by Boehringer Ingelheim.
18-Jan-2017 - A clear interchangeability pathway is essential for the US biosimilar market say developers as they begin reviewing the much-welcomed draft FDA guidance.
18-Jan-2017 - 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...
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developers to provide data from switching studies to demonstrate interchangeability with a reference biologic in draft guidance published today.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.