Biosimilar clinical trials are increasing but levels of physician oversight and regulatory decisions are still hurdles to overcome, say Parexel, PPD and Vince & Associates.
Unclear terms in US biosimilars laws and the high cost of filing with the Food and Drug Administration (FDA) has set the stage for legal battles according to a lawyer who spoke at AAPS this week.
Genentech has recommissioned plans to make a Californian facility the largest biologics plant worldwide after anticipated revenue drop from biosimilars did not materialise.
Novartis has joined the debate regarding the international nonproprietary names (INNs) of biologics saying some companies are casting unnecessary doubt on biosimilars under a guise of pharmacovigilance.
Corba Biologics has opted for a HyClone bioreactor to boost its antibody production capacity citing customer demand and biosimilars as the drivers for the investment.
The Governor of California has vetoed a bill set to constrict the dispensing of biosimilars due to its premature nature, much to the disappointment of Amgen and Genentech.
With in-house production and manufacturing capacity, as well as a deal with Merck Serono, India-based generics giant Dr. Reddy’s is looking to bring as many as four biosimilars to the EU market by 2019.
India’s biomanufacturing sector has immense potential, but policy, infrastructure and finance-related issues are holding it back, say both Biocon and analysts.
US acceptance of biosimilars is “not a question of if, only of when,” according to Hospira which received a European Commission (EC) OK of its Remicade copycat yesterday.
Baxter and Coherus Biosciences have become the latest firms to try and develop a biosimilar version of the RA treatment Enbrel in a new collaboration announced this week.
Mitsubishi Tanabe Pharma (MTPC) is closer to adding two plant-based expression techs to its manufacturing arsenal after Medicago shareholders back its takeover bid.
As California approves a Bill constraining biosimilar substitution, the US FDA says it is concerned at efforts to undermine strict federal legislation already in place.
inVentiv Health and Oncobiologics are employing a unique risk-sharing partnership to bring a number of the biggest blockbuster biologics to market as biosimilars.
Biosimilar developers such as Mylan and Pfizer are taking issue with FDA draft guidance that in some circumstances could extend biosimilar development timelines and discourage their development.
The Japanese joint venture between Dr. Reddy’s and Fujifilm has been called-off though both say future collaboration remains likely, especially in API production.
As anticipation swells over how the biosimilar market will shape up in the US, some contract biologic manufacturing executives don’t seem to think the size of the market is worth all of the hype yet.
Highly sought-after guidance on quality agreements for contract manufacturing organizations (CMOs) and biosimilar developers is expected in 2013, according to a list of future guidance documents released by the US Food and Drug Administration (FDA).
