In The News

• February 27, 2012
  "Switching Study Required for Biosimilar Interchangeability Draws Questions"
  Inside Health Reform
  D. Christopher Ohly
  Schiff Hardin partner Chris Ohly is extensively quoted in this article on the failure of FDA guidelines for biosimilar pharmaceuticals to address interchangeability. Mr. Ohly commented that, based on the FDA's limited comments in the recently released guidelines and other data, cross-over studies may well be required to establish interchangeability of a biosimilar product. He noted that the FDA said it is unlikely to approve a biosimilar as an interchangeable product based on an original application.
• February 13, 2012
  "New Biosimilar Path Is Anything But Predictable"
  BioWorld Today
  D. Christopher Ohly
  This article about recent guidance from the U.S. Food and Drug Administration on biosimilar drug development quotes Schiff Hardin partner Chris Ohly. Mr. Ohly, who focuses on pharmaceutical industry issues in the firm's Intellectual Property Group, notes that the guidance could encourage companies previously considering biosimilar development to proceed along that path.
• February 10, 2012
  "Biosimilar Guidance Silent on Industry's Biggest Questions"
  Law360
  D. Christopher Ohly
  Schiff Hardin partner Chris Ohly is quoted in this article about new guidance from the U.S. Food and Drug Administration regarding the development of generic versions of biological drugs. Mr. Ohly, a partner in the firm's Intellectual Property Group, points out that the guidance contains no information about clinical trial requirements or interchangeability, two factors that will greatly affect biosimilar development costs.
• February 1, 2012
  'Fresh from the biotech pipeline ? 2011'
  Nature Biotechnology
  D. Christopher Ohly
  This article about the U.S. FDA approval process for biosimilar drugs quotes Schiff Hardin partner Chris Ohly. Mr. Ohly, who focuses on pharmaceuticals in the firm's Intellectual Property Group, comments that companies moving through the biosimilar and interchangeable drug approval process may end up innovating their products as a result.
• January 27, 2012
  "BIO Vows to Protect Biosimilar Provisions from Health Reform Repeal Efforts"
  FDA Week
  D. Christopher Ohly
  Schiff Hardin partner Chris Ohly is quoted in this article about the potential severability of the Biosimilars Act from the Affordable Care Act in a forthcoming decision by the Supreme Court in litigation attacking the ACA's "individual mandate." He commented about possible turmoil in the generic pharmaceutical industry if the Affordable Care Act is overturned as a whole by the Court. Mr. Ohly, a partner in the firm's Intellectual Property Group, pointed out that the "individual mandate" is completely unrelated to the Biosimilars Act. He added that the Biosimilars Act can be readily severed from the rest of the health care reform law without difficulty and in a manner consistent with the Court's prior decisions about severability.
• April 25, 2011
  "Patents on the line"
  BioCentury
  D. Christopher Ohly
  In this article about challenges in the Supreme Court to patent protections, Schiff Hardin partner Chris Ohly is quoted regarding the standards used to invalidate a patent.
• February 11, 2011
  "Patent reform looks likely to pass this year"
  BioPharm Insight
  D. Christopher Ohly
  Schiff Hardin's Christopher Ohly, a partner in the firm's Intellectual Property group, is quoted in this pharmaceutical news service story on patent reform legislation. Mr. Ohly points out likely consequences of the legislation, including the significant change to first-to-file priority in patent applications.