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.

The introduction of first-generation biologics has heralded great advances in medical technology. As these innovative products mature, the concept of follow-on-biologics or biosimilars is of increasing interest to competitors. The term "follow-on-biologics" (FoB) refers to those biologics that have similar qualities to a novel, previously approved biologic, but are approved with less supporting data than the innovator product.

At MedImmune we recognize the importance of making healthcare affordable, but we also believe in incentives for innovation and a robust regulatory review process that is specific to the complex human-based biotechnology agents. The goal of introducing follow-on-biologics to the marketplace must not compromise current potency, purity, and safety standards as proven through premarketing clinical trials as well as postmarketing surveillance. We support legislation that addresses the uniqueness of biologics and puts patient safety first, while protecting the investment that research-driven companies make by ensuring substantial nonpatent exclusivity and an adequate opportunity to enforce patents.

MedImmune has some of the best manufacturing facilities in the biotech industry. These world-class facilities would give us the ability to produce follow-on-biologics products, should we choose to do so and if the legal and regulatory framework allowed. However, at the current time we see the strongest opportunities for the business in flexing its track record of innovation, developing its pipeline of potential biologic candidates to treat or prevent a number of debilitating or life-threatening diseases.  While we are not actively pursuing a FoB strategy, we will continue to leverage our innovative platforms to create patient-centered improvements in areas with proven mechanisms of action.

In the United States, the Public Health Service Act (PHSA) governs the approval process for biologics. However, unlike the Food, Drug & Cosmetic Act (FDCA), which has provisions for a generic drug approval process, PHSA does not currently provide a framework of regulations authorizing the FDA to approve a follow-on-biologic. In contrast, the European Medicines Agency (EMEA), the European equivalent to the FDA, has implemented an approval scheme that specifically distinguishes between follow-on-biologics and generic drugs. The EMEA recognized that "due to the complexity of biological/biotechnology-derived products the generic approach is scientifically not appropriate for these products." To date, the EMEA has approved several biosimilars products.

We believe that biotechnology is breaking past the boundaries of medical science and healthcare provision. MedImmune is committed to developing the next generation of biologics that will transform patients' lives. To do so, we require a supportive regulatory environment that incentivizes innovation and allows us to conduct cutting-edge research and development. We are proud to be part of this new biohealth sphere and look forward to continuing to revolutionize patients' lives.