At long last, it’s only a matter of time before the first biosimilar will be approved by the FDA. The race to be the first 3 biosimilars in the USA is on! How do I know this is important? I have the luxury of speaking to heads of biosimilar programs of big pharma, and characterization experts by attending our very own Terrapinn events.
Is regulatory holding biosimilars back? What needs to be defined? Characterization, manufacturing process, and IP are among the topic of discussion at the World Biosimilar Congress USA in San Diego, May 27 – 28, 2015; at the Mission Valley Marriot Hotel.
One of our past sponsors, Al Doig, from BPTC, has some insightful information as to where in biosimilars is the devil? The Devil is in the Details. See what Al means in his white paper below.
Download the white paper to find out about:
- The top 6 patent expiration for monoclonal antibodies are
- What manufacturing complexities are
- What are the big regulatory hurdles
- What are the implications for healthcare policy
- What’s the big race about
Get up to date with all things Biosimilars at the World Biosimilar Congress USA!