The target indications included anemia (six products) hereditary genetic conditions (four products), cancer prevention or treatment (two products), and neovascular macular degeneration, rheumatoid arthritis, and infertility (one product each).
A wide range of therapeutic proteins (e.g., tPA, interferon γ, and hepatitis B surface antigen) have been produced at laboratory scale using such systems. A small number of approved veterinary medicines (e.g., Intervet's porcilis pesti subunit vaccine) are commercially manufactured using such systems. The advantages of recombinant insect-cell–based production include high levels of intracellular expression and rapid cell growth on relatively inexpensive media. However, issues including low extracellular expression levels and the exact nature of post-translational modifications achieved have been cited as disadvantages of this system.
Perhaps the single most notable feature of the 2007 approvals is the number of biosimilar products that entered the market in the EU. Of the 14 products approved for the first time last year in Europe, five are biosimilars (Abseamed, Binocrit, Epoetin alfa Hexal, Retacrit, and Silapo; Table 1). This clearly illustrates that the biosimilar legislative framework developed by the EU works in practice. Another notable fact is that all five products are EPO-based. This is not surprising given that EPO is the single most lucrative biopharmaceutical on the market. EPO-based products represent three of the top 10 blockbuster biopharmaceuticals (Aranesp, Procrit/Eprex, and Epogen)1 , and relevant company annual reports show a cumulative annual market value in excess of $10 billion for these three products. The approval of biosimilar EPOs also confirms the practical feasibility of illustrating comparability of a glycosylated biosimilar to its reference medicine.
The remainder of this article focuses on individual products approved for the first time in 2007, with product information detailed in a monograph format. The information was drawn from regulatory sources and the web sites of sponsoring companies.2,3 Monographs detailing the products listed in Table 1 that had gained prior approval in some world region were included in previous articles.4–6 Therefore, they are not considered below.