AMCP Recommends Veto of California Biosimilars Bill

Senate Bill 598 Preempts FDA and Reduces Patient Access and Market Competition 

For Immediate Release

Alexandria, Va., September 6, 2013 — The Academy of Managed Care Pharmacy (AMCP) today urged California Gov. Edmund G. Brown, Jr. to veto Senate Bill 598, a bill that would restrict patient access to biosimilars, add wasteful regulatory burdens on pharmacists and lead to higher prices on prescription drugs by reducing competition. AMCP is also urging its over 1,000 members in the state to contact the governor to urge him to veto the bill.
The U.S. Food and Drug Administration is in the midst of studying biosimilars and deciding which ones are interchangeable with the similar biological products developed first. Biologics, which are made from living cells, are increasingly used to treat cancer, rheumatoid arthritis and other serious diseases. Biosimilars play a comparable role in relation to biologicals as generics do with traditional drugs: they’re follow-on versions of original biological medicines, independently developed after the original’s patent has expired, that are intended to treat the same diseases.
In a letter dated September 6, 2013, AMCP CEO Edith A. Rosato, RPh, IOM, wrote:
The legislation recognizes that the U.S. Food and Drug Administration has not yet fully implemented its policy to determine which biosimilars are interchangeable with reference innovator biologic products.  Yet, this legislation seeks to implement a state system for dispensing biosimilar products before this process is complete. Thus, this legislation is premature and impedes and hampers the use of these products.
The high costs of many of [biological] products threaten patient access to important therapies and place a strain on individuals, payers and federal and state governments’ attempts to manage prescription drug spending.  Since 2006 when biosimilars were introduced in the European Union, competition from biosimilars has resulted in average price reductions of 30%, and it is reasonable to expect similar savings for consumers and payers in the United States. …
This legislation also prohibits a pharmacist from dispensing a biosimilar unless the cost to the patient is the same or less than the cost of the prescribed biological product.  Generally, when states link the cost of a prescription to the ability of a pharmacist to dispense, the purpose of the legislation is to require disclosure of the cost implications so that the patient can make an informed purchasing decision.  The patient retains the ability to decide whether to pay the additional cost; access is not denied by law. However, this legislation removes patient choice between a biosimilar and innovator product based solely on cost.  The right of the patient to decide if they want to incur the additional cost is taken away.  …
Finally, this legislation does not recognize the value that biosimilars offer to patients and payers by enhancing access to safe and lower cost medications.  In fact, the California Public Employees’ Retirement System has opposed this legislation because it will prevent them from realizing cost savings that can benefit its members. …
AMCP believes that the requirements in this legislation will discourage appropriate substitution of interchangeable biologic products and has the potential to cost patients and payers unnecessary sums of money and threatens patient access to more affordable treatment.  [Emphasis added]
To read the letter in its entirety, click here or visit 
About AMCP  
The Academy of Managed Care Pharmacy is a national professional association of pharmacists and other health care practitioners who serve society by the application of sound medication management principles and strategies to improve health care for all. The Academy's nearly 7,000 members develop and provide a diversified range of clinical, educational and business management services and strategies on behalf of the more than 200 million Americans covered by a managed care pharmacy benefit. It is celebrating its 25th anniversary in 2013. More news and information about the Academy can be found at 
For more information, please contact:
Kevin Bruns | 703-683-8416 ext. 656