Institutional investors such as the UAW (United Automobile Workers) Retirement Medical Benefits Trust and the New York Common Retirement Fund issued a statement to industry notifying them of several factors that have or could stymie the introduction of biosimilars in the US and that are “of concern to institutional investors.”
The investors claim first and foremost that the information surrounding the biosimilar market in the US “is imbalanced. Noticeably absent is the safety record of the 14 biosimilars that have been marketed in the European Union (EU) since 2006. Data from companies that currently market biosimilars in Europe show no immunogenicity issues; an assertion affirmed by member states of the EU and the European Medicines Agency.”
As companies are “seeking to downplay the patient safety record of European biosimilars,” they have also “challenged the capacity of the FDA to promulgate rules and determine when biosimilars may be substituted for biologics,” investors said.
The investors specifically take issue with industry calls for different non-proprietary names for biosimilars, which they claim “could lead to prescribing errors.”
“In our view, assigning different names communicates to providers that the biosimilar is less effective, causing providers not to prescribe it and ultimately making it difficult for pharmacists to dispense,” investors said.
The call comes as the market for biosimilar manufacturers is set to open up when biologics accounting for $70bn in sales go off patent by 2017.
Controversial State Leg
Biotech company funds are also being used to help fund legislation in 18 states on biosimilars, which “have been expansive,” and impose requirements on pharmacists that are likely to impede patient access to biosimilars. The pre-emptive state legislation imposes “overly burdensome record keeping and communications requirements” for pharmacists, the investors contend.
“Specific political contributions to legislators acting on behalf of pharmaceutical companies have been widely reported by state and national press,” the investors say.
Companies have previously argued that the generic/brand name paradigm should not be used for the biosimilar conversation and that patients and pharmacists need to understand there could be differences between biosimilars and their reference counterparts.
Pay-for-delay?
An area of particular concern for delaying biosimilars to patients -- the patent-challenge process – also is front and center in the investors’ call to action. What has been previously established for small molecule drugs under the Hatch-Waxman Act and the requirement that pay-for-delay arrangements be disclosed to the FTC (Federal Trade Commission) “do not apply to biologics and biosimilars. Investors fear that without full disclosure of the value, terms and duration of these arrangements, investors and analysts will not be able to evaluate the risks associated with the transactions.”
Key information about any partnership or business deal related to biosimilars “should be fully disclosed to investors, including information about the value, terms and duration of the deal,” the investors suggest.
And Biopharma-Reporter will be delving deeper into the issues affecting biosimilars with a free virtual event on September 26. Join four industry experts as they discuss the development, manufacture and sale of such products in a 60 minute seminar hosted by our Editor-in-Chief Gareth Macdonald. Click here for more details...