Understanding New FDA’s Guidance on Biosimilar Product Development
The Food and Drug Administration released the first draft guidance on Biosimilar Products early February. The draft specifically contains 3 guidance documents on (1) Scientific Considerations; (2) Quality Considerations; and (3) Biosimilars: Questions and Answers Guidance. The issued guidance aims to help pharmaceutical industry comply with the requirements under the BPCI Act and to successfully prove that their product is biosimilar to a biologic product approved by the FDA. But the guidance raises many questions in the industry that has to be answered, including the cost of complying.
To explore and understand the new draft guidance, the Knowledge Group is putting together a panel of experts to help pharmaceutical industry and their advisers understand its implication. The speakers will share their expert opinions and best practices in a two-hour LIVE Webcast. A live interaction with the audience in a question and answer format is also included in this event.
Fiona Greer, PhD, Global Director of BioPharma Services Development,
Challenges for Characterization and Comparabilty testing of Biosimilars.
- Why is analytical characterisation essential throughout all stages of biosimilar development?
- What are the regulatory issues associated with characterization and comparability testing of Biosimilars to demonstarte Biosimilarity?
- Characterisation of the Innovator
- Side by Side Comparison of Innovator and Biosimilar
- What are the issues regarding the choice of Reference Product?
- How can we characterize complex protein/glycoprotein products? Which techniques, old & new, are suitable for comparability testing ? FDA have stated they will review applications based on “the totality of the evidence”.
Joseph A. Mahoney, Partner,
- “Biosimilar” vs. “Interchangeable” Statutory Definitions
- Marketing and Data Exclusivities Innovator receives
- Marketing and Data Exclusivities Biosimilar “interchangeability” exclusivity
- FDA Draft Guidance Documents
- Patent Protection Clues Provided by Guidances
- Patent Searching and Monitoring
- FTO Analysis
- FTO Analysis to Later Patent Exchange
- FTO Analysis: American Invents Act Issues, Caselaw
- FTO Analysis: Interpreting the Caselaw
- FTO Analysis: Preserving the Privilege
Sanya Sukduang, Partner,
Finnegan, Henderson, Farabow, Garrett & Dunner, LLP
- The BPCIA patent information exchange process
- The potential for stealth biosimilar applications who fail to disclose application to reference product sponsor and what Reference Product Sponsors can do about it
John J. Molenda, PhD, Counsel,
- Implications of Lovenox® and Abbott’s Citizen Petition on Biosimilars Development
Daniel W. McDonald, Partner,
Merchant & Gould P.C.
- Case study on how to use recent patent damages case law to exclude a patent owner’s entire damages case, resulting in an award of $0 in damages even when infringement was found.
- Tips on presenting and fighting patent damages claims, including how to apply recent damages case law to attack inflated damages claims by NPEs (sometimes called “trolls”).
Who Should Attend:
- Biotech/Pharma Attorneys
- General Counsel
- Senior Executives
- Consultants & Clients in the Biotech and Pharmaceutical Industries
- Biotech/Pharma Industry Lawyers
- Life Sciences and Health Care Practice Consultants/Advisors
- Senior Management
- Professionals coming from Biotech and Pharmaceutical Firms
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.
Following a Ph.D. in Protein Biochemistry from Aberdeen University, she joined M-Scan Ltd in 1984 to found the Biochemical Services …
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.
Joe Mahoney is a Registered Patent Attorney concentrating on patent matters relating to pharmaceuticals, medical devices, biotechnology and chemicals. His …
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 email@example.com.
Sanya Sukduang is a partner in Finnegan, Henderson, Farabow, Garrett & Dunner, LLP’s Washington, DC office. He concentrates on patent …
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.
John Molenda’s practice focuses on patent litigation at the appellate and district court levels, with an emphasis on biotech and …
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About SGS M-Scan
SGS Life Science Services is a leading contract service organization providing clinical research, analytical development, biologics characterization, biosafety, and quality control testing. Delivering solutions for pharmaceutical, biologics, and medical-device manufacturers, SGS provides clinical trial management (Phase I to IV) and services encompassing bioanalytical testing, data management, biostatistics, and regulatory consultancy. SGS also offers GMP/GLP contract laboratory services that include analytical chemistry, microbiology, stability studies, bioanalysis, extractables and leachables, virology, and protein analysis. With the recent acquisition of Vitrology, SGS expands its service offering for biologics in the areas of cell bank and virus seeds characterization, raw material and bulk harvest testing (sterility, mycoplasma, viruses), final product testing for residual DNA, and safety consultancy services. Operating 27 facilities in 14 countries, SGS Life Science Services represents the broadest global network of contract analytical laboratories.
About Mayer Brown
Mayer Brown LLP is a global law firm advising clients across the Americas, Asia and Europe. The firm’s multi-disciplinary Intellectual Property practice is uniquely positioned to provide a full range of services to its clients, including litigation and enforcement, counseling and prosecution, proceedings before the ITC and transactions. As many of the firm’s lawyers have earned technical degrees in such fields as biochemistry, chemistry, pharmacy, microbiology and chemical, mechanical and electrical engineering, they not only have a full understanding of IP law but also its practical application. Mayer Brown has extensive experience in handling issues related to the life sciences industry, including proven success in Hatch-Waxman litigation, representation of institutions in negotiating patent licenses, and successful patent, trademark and copyright litigation.
About Finnegan, Henderson, Farabow, Garrett & Dunner, LLP
With more than 375 intellectual property lawyers, Finnegan is one of the largest IP law firms in the world practicing all aspects of patent, trademark, copyright, and trade secret law, including counseling, prosecution, licensing, and litigation. Finnegan represents key innovators, including established multinational leaders as well as small, start-up companies, with IP assets that promise advancements in the life sciences field. Finnegan has delivered successful, sophisticated legal strategies to help pharmaceutical and biotech clients protect, advocate, and leverage their valuable IP assets. ]
Our clients are involved in a diverse area of biological products, such as antibodies, blood products, therapeutic proteins, and personalized medicines. From claim drafting and prosecution to developing winning litigation strategies, we provide a full range of services to our pharmaceutical and biotech clients. For more information, please visit www.finnegan.com.