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Biosimilars Action Plan Update

As an immediate follow-up to last week’s release of the FDA’s Biosimilars Action Plan, the Agency is announcing a public hearing for September 4, 2018 to gather stakeholder input on “FDA’s approach to enhancing competition and innovation in the biological products marketplace, including by facilitating greater availability of biosimilar and interchangeable products.” The hearing notice, to be published in the Federal Register on July 25th (see here), notes that the Agency has determined that a public hearing is the most effective way for it to hear from a diverse an broad group of stakeholders, from patients and health care providers to manufacturers and professional organizations.

The hearing notice provides a list of 9 specific questions on which FDA is soliciting feedback, and in particular on how it could use its existing statutory authority to regulate biological and biosimilar products to address those issues. In addition, the notice identifies several high-level goals under the Biosimilar Action Plan and requests any and all relevant information stakeholders are able to share with the Agency. Those goals are to:

  • Facilitate the efficient development of biosimilar and interchangeable products using state-of-the-art science;

  • Develop information resources, as well as scientific or regulatory tools, to streamline the development of biosimilar and interchangeable products;

  • Enhance the efficiency of FDA review of marketing applications for biosimilar and interchangeable products;

  • Provide additional scientific or regulatory clarity regarding FDA’s regulation of biological products, including FDA’s review and approval of marketing applications for biological products;

  • Increase health care provider, patient, and payor understanding of biological products, including biosimilar and interchangeable products; and

  • Support market competition by addressing attempts to game FDA requirements or otherwise delay market entry of competing biological products.

As we have mentioned in prior posts, registration for this type of FDA public hearing is done on a first-come, first-served basis and the conference center at FDA’s campus at White Oak does fill up quickly. Anyone who wishes to attend in person or present oral remarks during the event should sign up as soon as possible. This Part 15 hearing will also be webcast live for those who cannot travel to White Oak, Maryland or who do not get one of the coveted in-person slots. Although not available quite yet, when a webpage for the hearing is created on the site, interested parties can look there for more information.  It will be posted here:

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About this Author

Joanna Hawana, Mintz Levin, FDA Lawyer, Clinical Trials & Research Consumer Product Safety FDA Regulatory Health Care Compliance, Fraud & Abuse, and Regulatory Counseling Health Care Transactional Due Diligence
Of Counsel

Joanne counsels global clients on regulatory and distribution-related considerations to bringing a new FDA-regulated product to market and how to ensure continued compliance after a product is commercialized. She also advises on the business impact of new US federal and state actions that affect those regulated products, such as drugs, foods, cosmetics, electronic nicotine delivery systems, and medical devices, including in vitro diagnostics, lab tests, and mobile medical applications. In recent years she has been advising clients in different industries regarding FDA’s approaches to...

Muriel M. Liberto, Biotech, Pharmaceutical,Mintz Levin, Patent Prosecution & Strategic Counseling Patent Prosecution Patent Portfolio Strategy Patent Opinions IP Due Diligence Licensing & Technology Transactions

Muriel is a patent strategist trusted by her clients to help manage and grow patent portfolios covering their most important innovations. She uses her technical expertise and legal acumen to assist clients in obtaining exclusivity around key assets and ensuring they have space for growth. She guides clients in developing intellectual property strategies that are integrated with product development to maximize value by keeping IP in alignment with business goals. She has served as lead IP counsel for her clients undergoing diligence in connection with financings and acquisitions. In addition, she has worked on the other side of the deal, with both investors and companies evaluating opportunities. This dual experience brings unique perspectives to leverage on her clients’ behalf, whether they are conducting the diligence or are its target.

Muriel’s practice is focused on life sciences industries, with particular emphasis on biotechnology and pharmaceutics. Her clients range from academic and non-profit institutions to emerging and more established public and private companies.

Muriel has worked on a variety of technologies including molecular diagnostics, personalized medicine, gene therapy, small molecule therapeutics, vaccines, and drug delivery systems, including oral dosage forms, inhaled dosage forms, and tumor targeted theranostics. She has also worked on bioinformatics and machine learning based technologies leveraged to provide insight from genomic, epigenomic, and proteomic data for therapeutic applications; as well as natural language processing based techniques in clinical decision support.

Muriel has had considerable success with technologies that are difficult to protect in the current legal environment that persists in the US. She works closely with clients having technologies in these areas to develop worldwide patent strategies taking advantage of differences in the law across jurisdictions to provide the best possible coverage.

Muriel is committed to nurturing emerging life sciences companies in the local ecosystem through mentorship and training in conjunction with the Firm’s sponsorship of organizations dedicated to accelerating the development of technologies into successful businesses. Muriel also engages in pro bono legal work outside of patent law and has served on the firm’s Pro Bono Committee. She has assisted victims of persecution to obtain asylum in the United States, both through the affirmative application process and before the US immigration court. She has also assisted nonprofits with diverse matters ranging from drafting incorporation documents to obtaining federal tax-exempt status and negotiating the return of funds lost through a telemarketing scam.