What is a BioSimilar?
What is the Biologics Price Competition and Innovation Act (BPCIA) and when was it enacted?
Why are biologicals so important?
Are BioSimilars being approved in the US?
How about approvals of BioSimilars in Europe?
What impact did the US Hatch Waxman Act 1984 have on Biologics?
What is Merrifield Synthesis?
How are biologics different from small molecules?
What is a BioSimilar product under US Law?
What is needed to demonstrate BioSimilarity under U.S. law?
What are the general FDA guidelines for demonstrating biosimilarity?
Who determines substitution factors?
What is the naming problem with BioSimilars?
What is a sponsor?
Describe the problem with BioSimilar patenting and litigation
When huge amounts of money are involved in litigation, how does it affect BioSimilar patenting?
What should businesses do considering the many problems associated with BioSimilars?
How can Claim Maps help in working with BioSimilars?
What is your technical background and expertise?
Tell us about your experience as a patent lawyer?
What’s the most rewarding aspect of your practice?
Describe Schwegman’s capabilities in the areas of chemicals and pharmaceuticals