The US FDA's draft biosimilar guidelines easing clinical trial norms could cut costs and speed approvals, boosting Indian ...
(Reuters) -India's Biocon expects a 50% drop in costs for developing complex biosimilars as the United States has proposed to ease clinical testing for the drugs that make up more than 60% of its ...
To continue reading this content, please enable JavaScript in your browser settings and refresh this page. Most people have heard of the drug Humira. It costs $85,000 ...
Oncobiologics, a New Jersey maker of monoclonal antibody biosimilars for top-sellers like Humira, just closed out a $31 million round of financing. The privately held New Jersey company is ramping up ...
Please provide your email address to receive an email when new articles are posted on . An FDA draft guidance nixing the requirement for biosimilar manufacturers to conduct comparative efficacy ...
The updated guidance allows originators to cite existing comparative data, not exclusively from the United States, for clinical pharmacokinetic testing. This updated guidance in conjunction with ...
Biosimilars are driving down drug costs, expanding access to critical treatments, and creating space for future innovation. In this episode, Linda Choi MacDonald, EVP and Global Head of Commercial at ...
The Federal Trade Commission presents on Thursday its interim staff report, “Pharmacy Benefit Managers: The Powerful Middlemen Inflating Drug Costs and Squeezing Main Street Pharmacies.” It reveals ...