FDA is still to approve a biosimilar and has yet to issue final guidelines outlining the regulatory requirements for approval of a biosimilar in the US.
However, despite this fact at least six US states have taken it upon themselves to get the ball rolling and already have legislation in the works to allow originator biologicals to be substituted by biosimilars.
The US states of Illinois, Indiana, North Dakota, Pennsylvania, Texas and Virginia have all introduced bills to allow a pharmacist to dispense a biosimilar that has been deemed interchangeable by FDA, in much the same way as generics are treated.
In 2012, the Illinois General Assembly introduced a bill to amend the state Pharmacy Practice Act which would allow interchangeable biosimilar substitution, but only if certain conditions are met by prescribing physicians and pharmacies. One key condition of the bill is that a biosimilar must have been deemed by FDA to be interchangeable with the prescribed medicine for the specified indicated use. Whether the bill will be passed during 2013 remains to be seen.
Meanwhile, in Virginia, a bill has been introduced which permits pharmacists to dispense a biosimilar that has been licensed by FDA as interchangeable with a prescribed biological product unless the prescriber indicates such substitution is not authorized or the patient insists on dispensing of the prescribed biological product. The bill requires any pharmacist who dispenses an interchangeable biosimilar to inform the patient prior to dispensing the biosimilar, provide notification of the substitution to the prescriber, and record the brand name or the product name and name of the manufacturer of the biosimilar on the record of dispensing and the prescription label.
Despite this eagerness, however, two major biotechnology firms, Amgen and Genentech, are reportedly backing state bills in order to restrict pharmacists from being able to substitute originator biologicals with biosimilars.
Mr Scott Foraker, Vice President and General Manager of biosimilars at Amgen, has stated that Amgen ‘endorses state policies that would put patients first and, in doing so, increase confidence in the biosimilar pathway.’ The company adds that in order ‘to provide appropriate safeguards, patient medical records must accurately reflect the biologic[al] medicine a patient receives, by requiring that physicians be informed within a reasonable time after an interchangeable biologic[al] substitution has occurred.’
Genentech, which is owned by Roche, has also voiced its concerns that switching between originator biologicals and biosimilars presents a safety risk for patients. The company has also requested that biosimilars be uniquely identified and that extrapolation not be allowed without clinical trials in order to ensure the safety of patients.
These two companies will be affected the most when biosimilars hit the US market. Amgen, despite having made a deal with Actavis for biosimilars, makes arthritis blockbuster Enbrel (etanercept), the anaemia drugs Epogen (epoetin alpha) and Aranesp (darbepoetin alpha), and the drugs Neupogen (filgrastim) and Neulasta (pegfilgrastim) for protecting chemotherapy patients from infections. Genentech makes cancer blockbusters Rituxan (rituximab), Herceptin (trastuzumab) and Avastin (bevacizumab).
All these products, except Enbrel, which had its patent extended in the US from 2012 to 2028 [1], have lost or are set to lose patent protection in the next few years.
Both companies have stated, however, that the bills support biosimilars development.
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Reference
1. GaBI Online - Generics and Biosimilars Initiative. New Amgen Enbrel patent could block biosimilars until 2028 [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2013 Feb 8]. Available from: www.gabionline.net/Biosimilars/News/New-Amgen-Enbrel-patent-could-block-biosimilars-until-2028
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Source: Amgen, FDA Law Blog, Genentech, The New York Times
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