Biosimilars Regulatory and Legal Challenges: A Look Back and What’s Ahead
The development of biosimilars is increasing at a dynamic pace globally, and the biosimilar landscape in each jurisdiction is constantly evolving. Biosimilars offer improved access to effective biological therapies at reduced costs, which is one of the reasons why biosimilars continue to garner great interest among industry, regulators and consumers. At this point, many biopharmaceutical companies are looking for up-to-date guidance to understand the regulatory and legal landscapes for biosimilars in the United States, in Canada and in Europe.
In this two-hour LIVE Webcast, a panel of distinguished professionals and thought leaders organized by The Knowledge Group will provide an in-depth discussion on the regulatory and legal developments that biosimilar companies should know. Our speakers will share practical advice to succeed in this rapidly developing area of the drug industry.
Some of the major topics that will be covered in this course are:
- Biosimilar Legislation in the US
- The Purple Book of Biosimilars
- US Approval Pathways
- Interchangeability Requirements
- Biosimilar Approval Pathway in Canada
- Ongoing Regulatory and Legislative changes in Canada
- Litigation Landscape in Canada
- Existing Guidelines in Europe
- Review of Approvals in Europe
- Recent Regulatory and Legal Updates
Sterne, Kessler, Goldstein & Fox
- IPR’s on bio pharm and biosimilars in the US
- Post grant proceedings
- Biosimilars litigation
- US naming provisions
DLA Piper (Canada) LLP
- Canadian perspective
- Regulatory revisions on biosimilars
- Substantive amendments and guidance documents
- Biosimilars approved in Canada, regulatory approval
- Naming of biosimilars and biologics
- UK/European perspective / a good contrast to North American situation
- More free-wheeling with national court litigations
- High profile court cases
Who Should Attend:
- Counsel for BioPhama Products Manufacturing Companies
- Counsel for Biosimilars Manufacturing Companies
- Bio/Pharma and Related Attorneys
- Senior Members from Biological Products Manufacturing
- Senior Members from Biosimilars Manufacturing Companies
- Other Related/Interested Professionals
Tim Shea is Director in the Biotechnology/Chemical Practice Group at Sterne, Kessler, Goldstein & Fox P.L.L.C., where he has practiced for 20 years. Mr. Shea specialises in advising biopharmaceutical companies and research institutions on complex legal issues relating to the protection, enforcement, and transfer of their intellectual property. He practices primarily in the fields of immunology, molecular biology, genetic and medical diagnostics, biotherapeutics, and drug delivery. Mr. Shea has extensive experience advising clients on the creation and management of strategic patent portfolios, freedom-to-operate and patentability issues, complex prosecution strategies, validity and infringement issues, and due diligence investigations in connection with acquisitions and investments. He has published and spoken extensively on IP issues related to therapeutic antibodies and biosimilars. In addition, a significant portion of his practice involves counseling emerging companies on strategies for creating, protecting, and leveraging their IP assets to grow their businesses.
Mr. Shea’s full professional biography is available online at the following link: https://www.skgf.com/timothyshea
Tim Shea is Director in the Biotechnology/Chemical Practice Group at Sterne, Kessler, Goldstein & Fox P.L.L.C., where he has practiced …
Geoffrey Mowatt is certified by the Law Society of Upper Canada as a Specialist in Patent Law. His practice encompasses all areas of intellectual property law, with a focus on patent and trademark litigation—including pharmaceutical and biologic/biosimilar litigation under the Patented Medicines (Notice of Compliance) Regulations.
Geoff has experience in all aspects of intellectual property litigation, ranging from pre-litigation opinions to appearing before the Ontario Court, Federal Court, and Federal Court of Appeal. He has worked with counsel in other jurisdictions, including the United States, Europe and Australia, to co-ordinate the Canadian part of multi-jurisdictional lawsuits.
Geoff speaks frequently on patent litigation, intellectual property law, and developments related to pharmaceuticals, biopharmaceuticals and biotechnology, subjects on which he has also published extensively. Geoff is the Chair of the Canadian Bar Association Biotechnology Committee, and regularly lectures at the Masters of Biotechnology program at the University of Toronto. Geoff has also lectured at Osgoode Hall Law School for the patents course.
Geoff holds a M.Sc. from the University of Toronto where his graduate work involved geochemistry and computer modelling. He worked for two years as a consultant at an engineering firm prior to attending law school.
Geoffrey Mowatt is certified by the Law Society of Upper Canada as a Specialist in Patent Law. His practice encompasses …
Gareth is a qualified solicitor admitted to the Roll in England (and Wales) and Ireland. He obtained a first class degree from Oxford University in Biochemistry, and his PhD was carried out at the Dunn School of Pathology in Oxford in molecular genetics. Gareth has acted in many landmark UK IP trials concerning patent entitlement, biotechnology patent validity and infringement, SPCs (including EU Court of Justice references) and the interpretation of IP licences. He has also represented clients before the English Administrative Court and EU Courts in relation to challenges around marketing authorisation procedures.
Gareth has advised pharmaceutical and biotechnology clients on aspects of patent portfolio strategy, orphan exclusivity, paediatric exclusivity, Biosimilar applications, centralised procedure applications, interpretation of the medicines directives and associated guidance. Gareth also provides legal and technical advice concerning CHM appeals, agency scientific advice meetings and CHMP referrals and information meetings.
Gareth provides advice to clients on matters of governmental affairs drawing on his IP and medicines regulatory experience.
Gareth is a qualified solicitor admitted to the Roll in England (and Wales) and Ireland. He obtained a first class …
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NASBA Field of Study:
Business Law - Technical
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Areas of Professional Practice
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About Sterne, Kessler, Goldstein & Fox
Sterne, Kessler, Goldstein & Fox is an intellectual property law firm of 170+ professionals devoted solely to providing outstanding patent, trademark, Patent Office litigation, district court, and International Trade Commission legal services.
For more than 36 years, Sterne, Kessler, Goldstein & Fox helped companies build and enforce worldwide IP portfolios. Sterne Kessler has a proven track record at U.S. district courts, federal appeals courts, and the International Trade Commission, with worldwide oppositions, 175+ inter partes reviews, 50+ interferences, 400+ reexaminations, and covered business method patent reviews. They are the leader in both inter partes reviews and covered business method reviews in the biotech and pharmaceutical industry.
Sterne Kessler provides a full range of IP services, including: Patent preparation and prosecution, including management of worldwide prosecution, patent Office litigation, including oppositions, reexaminations, interferences, inter partes reviews (IPR), and covered business method (CBM) proceedings, patent litigation in U.S. district courts, state courts, the United States Court of Appeals for the Federal Circuit, and the United States International Trade Commission, strategic patent portfolio development and portfolio management, patent searching conducted at Sterne Kessler, as well as searching by vendors managed by Sterne Kessler, opinions on patentability, freedom to operate, patent infringement, and patent validity, advice on licensing, technology transfer, commercialization, monetization and due diligence; a number of their attorneys are Certified Licensing Professionals: Copyrights, Trademarks and Design Patents.
About DLA Piper (Canada) LLP
Building strong and substantial client relationships was the compass for DLA Piper’s business strategy and future development. Today, we are located in more than 30 countries throughout Africa, the Americas, Asia Pacific, Europe and the Middle East, positioning us to help companies with their legal needs around the world.
Our clients range from multinational, Global 1000 and Fortune 500 enterprises to start-up companies developing industry-leading technologies. They include more than half of the Fortune 250 and nearly half of the FTSE 350 or their subsidiaries.
With over 260 Canadian lawyers delivering services in more than 50 practice areas, DLA Piper Canada provides unparalleled value to our clients by combining the deep resources of a global firm with the highest level of personal service in the business. Our mission and vision is to be Canada’s premiere entrepreneurial full service law firm known for its leading edge specialties and comprised of lawyers who achieve results that exceed expectations through commitment to our clients and ourselves.
About Olswang LLP
Olswang LLP is an international law firm and a European and Asian leader in Technology, Media and Telecommunications. It also has established a commanding reputation for changing the face of business in a wide range of other industries, from Real Estate and Retail to Life Sciences and Leisure. Its partnership spans seven international offices across Belgium, France, Germany, Spain, the UK and Singapore, and, together with it 'best friends' network of leading independent law firms, it advises clients across EMEA, the US and South-East Asia.