Source: https://commercialbiotechnology.com/index.php/jcb/article/view/751
Timestamp: 2020-01-25 18:21:31
Document Index: 446129231

Matched Legal Cases: ['§ 351', '§ 262', '§ 351', '§ 262', '§ 351', '§ 7002', '§ 351', '§ 351', '§ 351', '§ 351', '§ 351', '§ 351', '§ 351', '§ 351', '§ 351', '§ 351', '§ 351', '§ 351', '§ 351', '§ 351', '§ 351']

Prospects and Challenges for the Commercialization of Biosimilars: Perspectives from the EU, Japan, and the US | Journal of Commercial Biotechnology
Vol 22 No 3 (2016), Articles
https://doi.org/10.5912/jcb751
Joanna Brougher+−
Owner & Principal, BioPharma Law Group PLLC Editor-in-Chief, Journal of Commercial Biotechnology
With many blockbuster biologic drugs coming off patent in the next couple of years, biosimilars are making significant breakthroughs in cost-effective biologic therapies. The global market for biosimilars is expected to increase nearly 30 fold from $1.3 billion in 2013 to $35 billion by 2020. To promote biosimilar development and commercialization in the U.S., the Biosimilars Act was signed into law in 2010 to establish an abbreviated pathway by which the FDA could approve biosimilar versions of previously licensed biological products. Since its enactment, two biosimilars have been approved in the U.S. This Article will discuss key aspects of the U.S., the EU and Japanese approval pathways and will explore their likely impact on the commercialization of biosimilar medicines.Â Â
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Joanna is a patent attorney who focuses her practice on all aspects of services related to patents in the life sciences. Joanna has experience counseling clients on the Hatch-Waxman Act and is monitoring developments involving biosimilars under the Biologics Price Competition and Innovation Act. Joanna is also an Adjunct Lecturer at the Harvard School of Public Health where she teaches a course on Intellectual Property and Health Technologies.Â She regularly speaks or lectures on intellectual property-related topics and is a frequent author of articles related to patent law and healthcare.Â In 2013, Joanna published a book called Intellectual Property and Health Technologies: Balancing Innovation and the Public's Health which examines the relationship between patents and public health in the context of medical technologies. Joanna received her J.D. degree from Boston College Law School, and is admitted to the Massachusetts and New York State Bars as well as the USPTO.