At the Forefront

The transformation of health and healthcare provision creates both great opportunities and great challenges. At MedImmune, we're committed to developing new partnerships to help ensure that solutions to public issues are found. New technologies and treatment possibilities require supportive regulatory and intellectual property processes that reward innovation and create a favorable environment for sustainable research and development. We are helping to make certain the environment for innovation remains buoyant for the biotech industry, thus helping to protect the health of future generations.

New treatment possibilities abound in the biotechnology sphere. As a leader in this industry, MedImmune believes cutting-edge technology will accelerate the development of novel antibody or antibody-like therapies and preventive medicines. Innovative properties will be engineered into antibodies so dosing frequency can be greatly reduced. Other antibodies will be developed to target multiple disease mediators or multiple epitopes on the same antigen to greatly increase drug efficacy.

The biotechnology industry is highly complex. Because of the cutting-edge nature of biotech research, it can take close to 20 years to nurture a therapeutic concept through to the delivery of a new therapy. This development process may then be followed by a lengthy course of regulatory approval, with no guarantee of commercial success. Investing to develop the next generation of treatments depends upon a strong patent system and intellectual property protection that safeguards innovation, particularly for rare conditions. MedImmune supports legislative action on patent law reforms that will improve our current system by strengthening patent quality and patent certainty. MedImmune is also committed to pursuing options to reduce development cycle times and increase success rates to potentially reduce the inherent costs of developing innovative medicines.

First-generation biologics introduced great advances in medical technology. As these and subsequent innovative biologic products mature, the concept of biosimilars is of increasing interest. The term "biosimilars" (also called "follow-on biologics") refers to products that are intended to copy previously-approved, innovator biologics and are submitted for approval based on similarity to the innovator product. Biologics are manufactured using live cells, making biosimilars unique and fundamentally different from small molecule generic drugs, which are virtually identical versions of innovator products.

The U.S. Food & Drug Administration (FDA) reviews and approves biologics under the provisions of the Public Health Service Act (PHSA) for use in the United States. The "biological standard" for approval requires demonstration that biologic products are "pure, potent, and safe" and that the manufacturing facility is designed to assure the product continues to be pure, potent, and safe. The recent passage of the Patient Protection and Affordable Care Act (PPACA) establishes a foundation for biosimilars to enter the marketplace. While the PPACA created a general framework, the law also allows FDA authority to establish rules and guidance that will govern the specific requirements and procedures for reviewing and approving biosimilars.

MedImmune supports a regulatory pathway for biosimilars that is focused on patient safety, product efficacy and continued incentives for biotechnology innovation. We believe a biosimilars pathway should ensure a robust regulatory review process similar to innovator product standards and that all biosimilars applicants should be required to conduct clinical trials that demonstrate sufficiently similar product safety, efficacy and immunogenicity relative to the innovator product.

At MedImmune, we recognize the need for continued incentives for innovator companies to invest in the development of novel, life-changing biologic medicines. We maintain that strong patent protection is the cornerstone of stimulating biologic innovation and we continue to support implementation of effective innovator-data exclusivity for innovator biologics.

We believe that the ongoing innovation in biologics will continue to bring substantial advances in medical sciences. MedImmune is moving ahead with a strong commitment to innovation, patient safety and product efficacy. We look forward to continuing to revolutionize patients' lives.