Understanding New FDA’s Guidance on Biosimilar Product Development

Following a Ph.D. in Protein Biochemistry from Aberdeen University, she joined M-Scan Ltd in 1984 to found the Biochemical Services Department. Here, she pioneered and applied developments in Mass Spectrometry for structural characterisation. She was appointed Director of Biochemical Services in 1988. At the same time, she was instrumental in establishing a facility in the United States where she was appointed Vice President. Dr Greer was responsible for establishing the Quality Management Systems and for directing Quality Assurance across the four M-Scan laboratories.

With over 30 years experience in the structural analysis of glycoproteins using instrumental techniques, she has published many articles on the use of mass spectrometry to fulfil regulatory characterisation requirements. She is regularly invited to give presentations at international meetings and has designed and presented various training courses. She is now Global Director for Biopharma Services Development, SGS M-Scan.

Joe Mahoney is a Registered Patent Attorney concentrating on patent matters relating to pharmaceuticals, medical devices, biotechnology and chemicals. His training in pharmacy (Doctor of Pharmacy) gives him a unique understanding of scientific and technical issues, bolstering his extensive legal experience. His patent litigation and counseling practice includes representing life sciences companies in Hatch-Waxman Act and other patent litigation; rendering opinions relating to the infringement, validity, and enforceability of patents; and negotiating and drafting patent licenses, co-marketing, and joint venture agreements for a variety of products. In addition, Joe leads IP due diligence assessments relating to acquisitions and mergers involving complex patent portfolios and pending litigation. Joe has been recognized by Chambers USA (2008-11) and Legal 500 (2008-11) as well as in IAM Life Sciences 250 – The World’s Leading Life Sciences Patent Litigators 2010, IAM Patent Litigation 250 (2011) and Best Lawyers’ 2011 Annual Guide to IP Law.

Sanya Sukduang is a partner in Finnegan, Henderson, Farabow, Garrett & Dunner, LLP’s Washington, DC office. He concentrates on patent litigation before the federal district courts and the U.S. Court of Appeals for the Federal Circuit, primarily in the areas of biotechnology, pharmaceuticals, and biologics. He has conducted all aspects of pre-trial, trial, and post-trial proceedings. Mr. Sukduang has extensive experience in cases arising from the filing of Abbreviated New Drug Applications (ANDA).

Mr. Sukduang lectures in the U.S. and abroad on biologics and biosimilars arising under the Biologics Price Competition and Innovation Act (BPCIA) and has authored numerous articles on this topic. Mr. Sukduang can be reached at 202.408.4377 or sanya.sukduang@finnegan.com.

John Molenda’s practice focuses on patent litigation at the appellate and district court levels, with an emphasis on biotech and Hatch-Waxman litigation. John’s appellate experience includes substantial involvement in twelve Federal Circuit appeals, advising clients on Federal Circuit practice, and serving as a guest lecturer on Federal Circuit practice at Fordham University Law School. John also served as a law clerk for the Honorable Alan D. Lourie of the US Court of Appeals for the Federal Circuit. John’s district court experience includes all aspects of pre-trial and trial proceedings, including a substantial role in a trial involving the groundbreaking PCR technology. John speaks regularly on current developments involving the Biologics Act and has authored several papers on the Federal Circuit’s law of claim construction. John earned M.S. and Ph. D degrees in Chemistry from Vanderbilt University, conducted post-doctoral research in biochemistry at NYU, and attended University of Michigan Law School.