The European Medicines Agency (“EMA”) initiated a public consultation on a proposed revision of its Guideline on “Similar Biological Medicinal Products” (the “Biosimilars Guideline”), available at the EMA website . The 2 April 2013 proposed revision would ultimately result in a new guideline replacing the current Biosimilars Guideline adopted in October 2005.
The draft revision of the Biosimilars Guideline
The draft revision of the Biosimilars Guideline reflects the main principles set out in the current version of the Guideline. It describes the concept of biosimilar and provides the general principles to be applied in the assessment of applications for marketing authorisation of biosimilars. This includes the choice of a reference biological medicinal product and the principles for establishing biosimilarity between the reference product and the biosimilar. Continue Reading
A collection of associations for higher education wrote to FDA Commissioner Margaret Hamburg urging a requirement for biosimilar applicants to certify that they have complied with the information exchange and patent dispute resolution provisions of the BPCIA. The concern raised is that:
“biosmilar sponsors can effectively circumvent every patent litigation provision of the statute simply by failing to provide timely requirement for notice and access to the reference product sponsor without meaningful consequences, despite the requirement for such notification.”
As stakeholders in the patent dispute resolution process, the higher education associations urge the Food and Drug Administration that:
“A mandatory yet simple requirement that biosimilar applicants certify their compliance with the notice and access provisions of the statute is warranted.”
This is another instance where manufacturers and trade associations believe FDA must play a role in refereeing potential disputes between pioneer companies and biosimilar applicants. Other close watchers, including the Biotechnology Industry Organization (BIO) and Pharmaceutical Manufacturers of America (PhRMA), have made similar comments in responses to the FDA draft guidances on biosimilars released earlier this year.
The November 5, 2012 letter was signed by:
- The American Council on Education (ACE)
- The Association of American Medical Colleges (AAMC)
- The Association of American Universities (AAU)
- The Association of Public and Land-grant Universities (APLU)
- The Association of University Technology Managers (AUTM) and
- The Council on Governmental Relations (COGR).
I recently participated in the American Conference Institute panel discussion “Maximizing Patent Life Cycles,” which was moderated by Pfizer Associate General Counsel Geoffrey Levitt. In case you missed it, “The Pink Sheet” covered the event in its article “FDA Denies Veramyst NCE Exclusivity, Revokes Torisel Exclusivity,” which expands upon several recent decisions from FDA on whether certain types of chemical compounds, known as “stable esters,” are eligible for non-patent exclusivity from FDA.
It also published the article “ANDA Changes May Require Paragraph IV Recertification, New 30-Month Stay,” which includes my comments from the event on the trend in the amending of generic drug applications to adjust to developments in ongoing patent litigation.
Applicants for marketing authorisation for biosimilars in the European Union (“EU”), under certain conditions, will be able in the near future to use batches of reference biological medicinal products sourced from outside the European Economic Area (“EEA”) in pre-clinical and clinical studies that are part of the comparability exercise preceding authorisation of biosimilars. On 28 September 2012, the European Medicines Agency (“EMA”) announced that it has updated its procedural advice document for applicants for marketing authorisation for biosimilars to reflect this change.
As a result, pharmaceutical companies developing biosimilars in multiple jurisdictions both within and outside the EU would be permitted to conduct related comparability studies with batches of the reference medicinal product sourced from outside the EEA without the need to repeat the studies with EU-sourced reference product batches. This would simplify the global development of biosimilars and would avoid the duplication of studies. The requirement that the reference biological medicinal product is authorised to be placed on the market in the EU is, however, maintained. Applications for marketing authorisation in the EU for biosimilars relying on a reference medicinal product which is not authorised in the EU would not be permitted.
The new regime will apply after the adoption of the revised EMA Guideline on similar biological medicinal products (CHMP/437/04) (“EMA Biosimilars Guideline”). The draft of the revised Guideline is expected to be published and released for public consultation in the beginning of 2013. The expected date for the adoption of the revised EMA Biosimilars Guideline is not yet announced. Continue Reading
The biosimilar biological product development (BPD) fee has been set at $195,880 (10% of the full application fee). This is the amount due when a sponsor submits an investigational new drug (IND) application for a biosimilar (or within 5 days of FDA granting a BDP meeting request – whichever occurs first).
When a sponsor is ready to submit a fully-developed biosimilar marketing application, the application fee for FY 2013 is $1,958,800 ($979,400 if the application does not include clinical data).
Notably, President Obama’s budget for FY 2013 projected approximately $20 million to be collected by the federal government in biosimilar user fees. Based on the just-announced user-fee rates, therefore, a maximum of 10 biosimilar marketing applications have been anticipated, and probably somewhat fewer depending on whether (and how many) INDs are anticipated. However, even if we see half that many applications in FY 2013, it will still be enough to trigger a host of novel issues, including the sharing of each application with the corresponding pioneer and the initiation of the biosimilar patent exchange procedures.
FDA published details of the user fees in an August 1, 2012 federal register notice.
President Obama recently signed into law The Food and Drug Administration Safety and Innovation Act (FDASIA). FDASIA will reauthorize for another five years the Prescription Drug User Fee Act (PDUFA V) and the various related user fee agreements between the drug and device industries and FDA. FDASIA includes provisions related to drugs, devices, generic drugs, and biosimilar biological products.
Below is a summary of certain key provisions pertaining to innovator and, where specified, generic drugs and biosimilar biological products. Continue Reading
With the 5-4 decision from the U. S. Supreme Court upholding almost the entire Patient Protection and Affordable Care Act, for those who were hoping for a fresh opportunity to re-debate the biosimilars statute, and perhaps plug some holes or make some basic changes to the law, those hopes have been dashed for now.
While the merits of the Biologics and Price Competition Act were not in play during the Supreme Court’s evaluation of the constitutionality of PPACA, few changes to the approval and regulations of medicines in this country have had the potential for such a large effect on what medicines will be available to patients. Prior to enactment, there was no abbreviated pathway for approval of biologic medicines under the Public Health Service Act. BPCIA, buried within PPACA, created that pathway in the U.S.
With Thursday’s (June 28, 2012) Supreme Court decision, any remaining legal debris has been cleared from the path and it looks like biosimilars in the U.S. will march ahead.
On Tuesday afternoon, three of Hogan Lovells’ Appellate practice partners will provide an analysis of some of the key decisions that will impact businesses as the Supreme Court concludes its current term.
Neal Katyal, former Acting Solicitor General of the United States and Appellate practice Co-Director, Cate Stetson, Co-Director of our Appellate practice; and Chris Handman, a seasoned Appellate partner, will conduct a 30-minute webcast on the ramifications of decisions handed down by the high court this term, which may include the Affordable Care Act, and how the three key cases challenging aspects of President Obama’s healthcare plan will be resolved. As previously posted, the outcome of the decisions on the Affordable Care Act could have direct implications for the U. S. biosimilars pathway.
The half-hour program, which begins at 1 p.m. on June 26, will also provide essential background on the Supreme Court, including the composition, recent personnel changes, and background on the Justices, and explain the impact of these structures on the decisions.
Register online for the free webcast.
The usual suspects from regulated industry, patient and physician groups turned out for the U.S. Food and Drug Administration’s public meeting on the biosimilars guidances. Now that the draft guidances have been out for several months and the FDA has a stack of comments to consider, the dialogue has moved from the theoretical to the practical: How is this really all going to work?
Stakeholders lined up for their turns at the podium at the Public Hearing held on May 11, 2012. To be sure, there were the predictable disagreements among stakeholders on issues such as naming and interchangeability, in addition to the now-familiar (and sometimes conflicting) views on the need to protect patient safety, encourage product innovation, and create meaningful cost-savings. However, the strong consensus that FDA should implement an education and communication plan about biosimilars was noteworthy. For example, a speaker from the American Pharmacists Association said pharmacists don’t know what to expect or do when they start seeing prescriptions for biosimilar products. Patient advocates and physician groups also said their constituents will need additional educational materials and are interested in interactive presentations from FDA on the appropriate use of these new products.
It’s not clear what steps FDA will take to articulate clear policy and provide guidance in these areas. At the hearing, however, the agency asked speakers for details and supporting data, and encouraged everyone to submit these and other concrete suggestions on implementation to the docket (FDA-2011-D-0618), which is open until May 25th.
While a Supreme Court ruling on the constitutionality of the healthcare reform law is not expected until June, sponsors and regulators continue to lay the groundwork for biosimilars in the U.S. An unintended consequence of embedding the Biologics Price Competition and Innovation Act within PPACA without a severability clause leaves the biosimilars law vulnerable to the fate of constitutional challenges to more controversial parts of the Affordable Care Act.
The Supreme Court recently concluded three days of oral argument challenging the constitutionality of several provisions of PPACA. There was general agreement amongst the petitioners, defendants and the Justices that the biosimilars provisions are “peripheral” to the challenges under review by the Court. Nevertheless, it remains possible that if the Court decides any one provision (such as the so-called “individual mandate”) is unconstitutional, rather than parsing out the constitutional bits, even those recognized to be peripheral to the provisions at issue, the Court could strike down the entire Act to let Congress sort it out. So even though “the biosimilar thing,” as described by Justice Breyer, would seem to stand on its own without the other parts of the Act, the BPCIA could be swept into a sweeping decision that would invalidate the biosimilars pathway along with the rest of the Act.
The BPCIA was the result of significant bipartisan effort and support in both the House and Senate. FDA reports (PDF) at least 35 requests for biosimilar pre-IND meetings as of February 15 and is holding a public meeting on the three issued draft biosimilar guidances in May. If the Supreme Court throws out the BPCIA with the bath water, it is reasonable to expect that the law would be re-enacted as a stand-alone. However, as we head into the presidential election season, the ability or will of Congress to enact any laws may come to a halt. There is little profit here in speculation, but in terms of setting expectations, it is possible that the BPCIA would come off the books temporarily, leaving many interesting questions about the legal significance of the gap period if the law were re-enacted in, say, early 2013.