Biotech Values

[Biopharm investor]

Generic biologics bill introduced in US

US lawmakers introduced legislation on Wednesday that would create a pathway for approval of generic formulations of biotechnology drugs that is closer to that which is in place for chemical compounds.

Under the proposal, companies would be allowed to manufacture biogeneric or biosimilar versions of a brand-name biotech product after it has been on the market for five years, rather than the 14 years advocated by certain companies in the biotechnology industry. The legislation would also allow the FDA to determine what studies are needed to determine whether a generic biologic drug is as safe and effective as the original product, and to decide if the formulations are interchangeable with the brand-name drug.

Sanford C. Bernstein analyst Ronny Gal has forecast that sales from biosimilars in the US may range from $4.9 billion to $12.6 billion in 2015.

Source: FirstWord