Analysis of EIB H.R.1548

Analysis of “Pathway for Biosimilars Act”

The “Pathway for Biosimilars Act,” H.R. 1548 would develop a safe and effective process for the approval of follow-on versions of revolutionary biologic medicines. The lab introduction example landmark legislation creates a pathway for less expensive versions of biologic drugs thtopics to write an informative essay on write an autobiographyat maintain the current high patient safety and scientific standards.

Currently,what does it mean to be an american essay patients can rely on the fact that any generic drug they take is the “same” as the brand name product, which has already been proven safe and effective. The “Pathway for Biosimilars Act,” sponsored by Representatives Anna Etopics to write an informative essay on write an autobiographyrugs and ensures that patients are not subjected to unproven and potentially unsafe products.

Specifically, H.R. 1548 would:

Require rigorous clinical trials for approval and new application.
Applications for biologics must meet rigorous safety standards, including submission of analytical studies, animal studies and clinical study or studies. Exclusively grants the FDA authority to waive the studies requirement, however, permission can be granted only after the FDA publishes final guidance advising that it is scientifically feasible to determine immunogenicity without additional studies.

Prohibit copies of copies.
Biologic products are complex, living organisms. To maintain the highest standards of quality, safety and “interchangability,” H.R. 1458 applies only to products that are first licensed. Therefore, copies of copies would not be allowed.

Acknowledge the scientific differences between biologics and traditional drugs.
Biologics are much more complex than traditional pill products since they are created from living cells as opposed to a chemical reaction. As a result, the data collected to prove a biologic safe and effective is unique and applicable only to that product and not to a generic replication of a similar product. H.R. 1458 understands the complex nature of manufacturing drugs from living cells, and instead creates a process for approval that is tailored to the unique demands of these innovative medicines.

Empower the FDA to conduct post-marketing safety studies.
H.R. 1458 would allow the FDA to require biosimilar applicants to conduct post-marketing clinical trials or studies and include a plan for post-marketing safety monitoring. This bill understands the inherent differences between biologic products and their follow-on versions. Subsequently, it ensures that a rigorous oversight process is in place to ensure that these unique copies with their own unique properties are safe for patient use.

Maintain the standard for “interchangeablility.”
Under current law, the FDA advises patients that brand name drugs and generic copies are interchangeable if they have the same active ingredient, same dosage and identical strengths or concentrations. Due to the complex nature of manufacturing biologics, such guarantees cannot be made. H.R. 1548 prohibits the FDA from designating a similar biological product as interchangeable or substitutable for the reference product, thereby leaving such decisions to treating physicians.

Preserves incentives for innovation.
H.R. 1548 would provide twelve years of data exclusivity to ensure innovators are motivated to make the risky investments necessary to discover new treatments and cures.