Key Issues Impacting The Future of Biosimilars. Foley & Lardner Life Sciences Transactions Conference San Diego September 30, 2009 Michael A. Swit, Esq. Vice President. Standard Disclaimers. Views expressed here are solely mine and do not reflect those of my firm or any of its clients.
Key Issues Impacting The Future of Biosimilars
Foley & Lardner
Life Sciences Transactions Conference
San DiegoSeptember 30, 2009
Michael A. Swit, Esq.
Overview of Current Situation in Europe
Regulatory and Scientific Issues
Product Development Issues
U.S. Legislative Options
Somatropin - 2 “Biosimilar Products”
Erythropoietin Alpha- 3 “Biosimilar Products”
Erythropoietin Zeta - 2 “Biosimilar Products”
Filgrastim- 6 “Biosimilar Products”
Lynchpin to traditional generic process – depends on:
Pharmaceutical “equivalents” – active ingredient, dosage form, strength, etc., must be SAME
Highly unlikely with Biosimilars –
Characterization – still a challenge even for the innovators – clinical trials may be needed to show comparability after process changes
Chances of “equivalence” conclusions faint as even a single amino acid can throw off conclusion (e.g., HGH)
Lovenox – only 70% characterized (but, is under an NDA)
Janet Woodcock, Director, Center for Drugs (before Congress, March 2007):
“there is general recognition that the idea of sameness, as the term is used in the generic drug approval process under the Federal Food, Drug, and Cosmetic (FD&C) Act and applied to small molecules, will not usually be appropriate for more structurally complex molecules of the type generally licensed as biological products under the Public Health Service Act.”
Lynchpin to generic process – depends on:
Bioequivalence study (occasionally clinical studies with efficacy endpoints – e.g., topicals) –
Accurate predictability also allegedly an issue with Biosimilars
Biosimilars – even under an abbreviated pathway, will most likely more resemble an NDA than an ANDA – clinical studies to show efficacy and monitor immunogenicity concerns likely
Omnitrope® -- Sandoz’s HGH product – rumored to have cost tens of millions of dollars to develop
Substitution-- core of classic Generic Industry Business Model
Depends on therapeutic equivalence
Allows for minimal sales forces
Multiple generics common – drives price to commodity status
Biosimilar world –
Substitution – aka “interchangeability” -- may evolve, but on a very, very limited basis
Woodcock – must be able to handle repeated brand/follow-in switching without adverse events
HHS – June 2007 letter to Senate HELP Committee – no interchangeability
Thus, business model will not be multiple generics & not a commodity
Without interchangeability, the Generic’s Biosimilar IS really a branded drug
Classic Generic – substitutability pushes sales
“Generic” – will have to go out and detail
Not their sweet spot traditionally
Will they run into greater resistance on “substitution” from doctors and patients?
Innovator – may need to distinguish vs. its “generic”
Internal and external pressure for outcomes studies
Classic Generic – many sources of API
Technological barriers to API development greater; fewer sources
Foreign sources – particularly from China – will be under great scrutiny from FDA, even more so after Heparin scandal
Immunogenicity concerns are very high –
FDA -- on record that immune response is “impossible to predict”
see Dr. Janet Woodcock, FDA Deputy Commissioner, Congressional Testimony, March 26, 2007
Price drives– and multiple generics drive price down
Insurance coverage follows ANDA approval
Marketing – cost sells; little need for formal sales & marketing staff
Legal Pathway – clear under Waxman-Hatch Act
Not therapeutically equivalent
Not same molecule
Price difference to brand likely smaller
Separate coverage likely needed for the Biosimilar
Will require professional sales and marketing staffs to drive utilization vs. “Brand”
Legal Pathway –
505(b)(2) – case-by-case
PHSA -- nonexistent
Top Democrat pushes for action on biotech drugs
By MATTHEW PERRONE – 18 hours ago (June 8, 2009)
WASHINGTON (AP) — As the Obama administration renews its health care reform effort on Capitol Hill, a top Democrat is calling for speedy action on a years long effort to create generic competition for costly biotech drugs.President Barack Obama used his weekly radio address on Saturday to call on Congress to act on his proposal to overhaul the nation's health care system.
In a letter Monday, Rep. Henry Waxman, D-Calif., reminded the president of his stated commitment to lower the price of biotech drugs, high-tech injectable medications that cost more than $40 billion per year.
Call, e-mail, fax or write:
Michael A. Swit, Esq.
The Weinberg Group Inc.
336 North Coast Hwy. 101
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Michael A. Swit, Esq., is a Vice President at THE WEINBERG GROUP, where he develops and ensures the execution of a broad array of regulatory and other services to drug, biologics and medical device/diagnostic clients seeking to market products in the United States. His expertise includes product development strategies, compliance and enforcement initiatives, recalls and crisis management, submissions and related traditional FDA regulatory activities, labeling and advertising, and clinical research efforts. Mr. Swit has been addressing critical FDA legal and regulatory issues since 1984. His multi-faceted experience includes serving for three and a half years as corporate vice president, general counsel and secretary of Par Pharmaceutical, a prominent, publicly-traded, generic drug company and, thus, he brings an industry and commercial perspective to his work with FDA-regulated companies. Mr. Swit then served for over four years as CEO of FDANews.com, a premier publisher of FDA regulatory newsletters and other specialty information products for the FDA-regulated community. His private FDA regulatory law practice has included service as Special Counsel in the FDA Law Practice Group in the San Diego office of Heller Ehrman White & McAuliffe and with the Food & Drug Law practice at McKenna & Cuneo, both in the firm’s Washington office and later in San Diego. He first practiced FDA regulatory law with the D.C. office of Burditt & Radzius.Mr. Swit has taught and written on a wide variety of subjects relating to FDA law, regulation and related commercial activities, including, since 1989, co-directing a three-day intensive course on the generic drug approval process and editing a guide to the generic drug approval process, Getting Your Generic Drug Approved. A former member of the Food & Drug Law Journal Editorial Board, he also has been a prominent speaker at numerous conferences sponsored by such organizations as RAPS, FDLI, and DIA. A magna cum laude graduate of Bowdoin College, he received his law degree from Emory University Law School and is a member of the California, D.C. and Virginia bars.
For more than twenty-five years, leading companies have depended on The Weinberg Group when their products are at risk. Our technical, scientific and regulatory experts deliver the crucial results, using sound science, to get products to the market and keep them there.
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