Policies & Legislation
The US Food and Drug Administration (FDA) has published its final guidance document on questions and answers related to biosimilar development and the Biologics Price Competition and Innovation Act of 2009 (BCPI Act).
On 10 September 2021, acting US Food and Drug Administration (FDA) commissioner Janet Woodcock, sent a letter to the US Patent and Trademark Office (PTO), outlining the agency’s concerns around drug patents and competition.
The Bolstering Innovative Option to Save Immediately on Medicines Act (BIOSIM Act) was introduced in the US on 22 April 2021. This hopes to encourage greater uptake and use of biosimilar therapies by increasing biosimilar reimbursement for healthcare providers in Medicare Part B .
As of 5 May 2021, South Korea has updated the re-examination periods for post-marketing surveillance (PMS) of approved drugs. This now includes a four-year re-examination period for PMS that can now be granted for paediatric drugs approved based on both ‘domestic’ and ‘foreign’ clinical trials.
Within the pharmaceutical industry, the biosimilars business is growing and consolidating both internationally and locally. It is within this framework that MERCOSUR announced the new tariff to be implemented.
The new trade agreement between Mexico, the US and Canada, now called the T-MEC entered into force on 1 July 2020.
To promote the use of generic medicines in Peru, on 31 October 2019, the Executive Branch published regulations through Supreme Decree No. 026-2019-SA, which established mechanisms to ensure access to lower-cost medicines. The decree recognizes the need to adopt measures that favour the population’s access to essential medicines, biological products, and medical devices.
China has made changes to its patent law which were enacted on 1 June 2021. The revisions mean China’s new patent law system resembles the US Hatch-Waxman approach and include a patent linkage system and patent term extensions.
On 17 June 2021, the US Supreme Court ruled to uphold the Affordable Care Act (ACA) and Obamacare. This ensures the current pathway for biosimilars to reach the US market will be maintained which will provide access to cheaper versions of expensive biological therapies.
The project known as the Medicines Law 2, led by a Joint Commission, seeks to settle discrepancies between senators and deputies regarding the sale of bioequivalent and generic medicines in Chile. The project, which is in its third stage, amends the Health Code to regulate generic drugs in order to prevent the vertical integration of pharmaceutical companies and pharmacies. In this way, it seeks to solve some pending issues left by the current drug legislation.