Amgen Response to Recent New York Times Story "Biotech Firms, Billions at Risk, Lobby States to Limit Generics"

THOUSAND OAKS, Calif., (Feb. 1, 2013)

The article "Biotech Firms, Billions at Risk, Lobby States to Limit Generics," published on Jan. 29 failed to report 1) that Amgen is developing both original biologics and biosimilars and 2) that our support for state pharmacy acts is based on our belief that enhanced safety monitoring and transparency of substituted biologics is in the interest of patient safety.

Last week, with our oncology biosimilars partner Actavis, we disclosed that we are developing four biosimilar versions of cancer treatments. Given Amgen's active involvement in originator medicines and as a future manufacturer and supporter of biosimilar medicines, we believe that no matter what biologic is used, the safety of all patients is of paramount importance. Hence, we openly support consistent, patient-focused policies at federal and state levels. 

States' efforts to create substitution rules that strengthen communication between physician, pharmacist and patient will help accelerate the successful implementation of the U.S. biosimilars pathway.

In response to the Times' reporting, we want to make clear a few key facts:

• To realize the promise of biotechnology for patients, we must acknowledge both the potential and the limitations of these complex medicines and seek science-based public policy.
• Biologics are complex, and with today's technology are made in living cells. 
• We know from experience that biologics can be highly sensitive – from cell line to manufacturing processes to storage environment and handling. This means that monitoring (pharmacovigilance) in patients is required throughout a biologic medicine's lifecycle.
• With biologics, there is an inherent risk of adverse reactions for patients that can occur with any biologic product over time, sometimes up to several months after the treatment period. 
• One area where policy can support patient safety is enabling the tracking and tracing of biologics during and after a patient's period of treatment. 
• State drug substitution laws and rules were written to address brand and generic drug dispensing. It is not clear how state laws as written would handle biologics for the purpose of substitution, given this possibility with the passage of the federal Biologics Price Competition and Innovation Act.  Accordingly, Amgen is engaged with state decision makers and stakeholders to help establish science-based policy to govern biologic substitution.
• Traceability measures, like accurate patient records, assist manufacturers and regulators by providing important data through routine surveillance of product quality and patient treatment outcomes. This means having efficient systems to ensure that patient treatment records accurately reflect not only those biologic medicines administered directly to the patient by the physician, but also those biologic medicines that are prescribed by the physician and dispensed to the patient by a pharmacist.
• In most cases, the physician will select a biologic therapy and administer it to the patient; thus ensuring an accurate record of the actual product received by the patient.
• However, in some cases a pharmacist may be authorized by state law to provide an alternative Food and Drug Administration (FDA) approved product that is different than the one prescribed. 
• Safe substitution of biologics and biosimilars requires not just that medicines are safe – but also that the doctor is notified about the actual product dispensed when different from that prescribed, and can maintain the patient record accordingly.
• In the circumstance that a biosimilar has been deemed interchangeable by FDA, Amgen supports public policy that ensures communication between the pharmacist and the physician within a reasonable period after a substitution has occurred. 

Biosimilars will have an important role in providing additional treatment options for some patients, provided they are safe and effective. However, biosimilars are a new initiative in the U.S. with many scientific and administrative challenges and nuances. These could have important implications for patients, health care providers, states, payers, other federal agencies, and more as we seek to introduce this new class of medicine into the healthcare system. Amgen asks that clarity and full representation of the facts is part of any public discussion on this important matter.