Policies & Legislation

FDA publishes final Q&A on biosimilar development and the BPCI Act

Home/Policies & Legislation | Posted 15/10/2021

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).

FDA voices concerns around drug patents and competition

Home/Policies & Legislation | Posted 08/10/2021

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.

USA BIOSIM Act introduction

Home/Policies & Legislation | Posted 17/09/2021

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 [1].

South Korea includes data exclusivity period for paediatric drugs approved abroad

Home/Policies & Legislation | Posted 10/09/2021

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.

MERCOSUR: new tariff for biological and biosimilar without Latin equity

Home/Policies & Legislation | Posted 03/09/2021

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.

New trade agreement between Mexico, the US and Canada

Home/Policies & Legislation | Posted 27/08/2021

The new trade agreement between Mexico, the US and Canada, now called the T-MEC entered into force on 1 July 2020.

Use of generic drugs is promoted in Peru

Home/Policies & Legislation | Posted 23/07/2021

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.

A new dawn for China’s patent law

Home/Policies & Legislation | Posted 16/07/2021

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.

Affordable Care Act to stand in USA

Home/Policies & Legislation | Posted 09/07/2021

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.

Proposals for the commercialisation of generics move forward in Chile

Home/Policies & Legislation | Posted 02/07/2021

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.

President Biden signs ‘Advancing Education on Biosimilars Act’

Home/Policies & Legislation | Posted 04/06/2021

US President Joe Biden has signed the Advancing Education on Biosimilars Act of 2021, authorizing the Food and Drug Administration (FDA) to educate patients and healthcare providers about the benefits of biosimilars. This follows the reintroduction of the Bolstering Innovative Option to Save Immediately on Medicines Act (BIOSIM Act), which will increase reimbursement for biosimilar drugs.

Teva under scrutiny in EU pay-for-delay investigation

Home/Policies & Legislation | Posted 31/05/2021

In March 2021, the European Commission opened a formal investigation into alleged anti-competitive – ‘pay-for-delay’ – conduct, by the Israeli generics giant Teva Pharmaceutical Industries (Teva).

EU and Brazil health authorities enter partnership

Home/Policies & Legislation | Posted 21/05/2021

Health regulatory authorities in the European Union (EU) and Brazil entered a partnership to ensure mutual recognition and regulatory harmonization to improve human and animal health.

Bills increase access to affordable drugs in the US and the Philippines

Home/Policies & Legislation | Posted 14/05/2021

In the opening months of 2021, a bill was proposed to make more biosimilars accessible to a greater proportion of the US state of Minnesota’s residents. In addition, a bill was passed in Wisconsin that will give pharmacists the ability to recommend cheaper drug options. And, in the Philippines, a bill has been filed to encourage the use of biosimilar drug products.

EU Court of Justice upholds Lundbeck fines over pay-for-delay

Home/Policies & Legislation | Posted 07/05/2021

On 25 April 2021, Danish drug company Lundbeck and four generic drugmakers lost their appeal against European Union antitrust fines of Euros 146 million (US$172 million), imposed in 2013.

Colorado to import drugs from Canada and beyond

Home/Policies & Legislation | Posted 30/04/2021

In 2019, a law was passed in the US state of Colorado to allow the import of prescription drugs from Canada. A bill to expand drug imports, and include those from additional nations, cleared at House committee on 7 April 2021. This hopes to see imports from additional countries like Australia, France and Japan.

Federal Court maintains decision on infliximab patent validity

Home/Policies & Legislation | Posted 23/04/2021

On 21 January 2021 and following appeal, the US Federal Court again found that the patent held by The Kennedy Trust for Rheumatology Research regarding the use of infliximab (Janssen’s Renicade) is valid and infringed by Hospira’s biosimilar, Inflectra.

Teva not liable in US due to FDCA implied preemption

Home/Policies & Legislation | Posted 16/04/2021

In early 2021, implied preemption related to the Federal Food, Drug and Cosmetic Act of 1938 (FDCA or the Act) has prevented generics manufacturer Teva Pharmaceuticals (Teva) from being held liable for three different failure-to-warn theories.

China improves generics injection consistency evaluation

Home/Policies & Legislation | Posted 09/04/2021

China’s National Medical Products Administration (NMPA) announced regulatory improvements to the generic injections’ quality and efficacy consistency evaluation in May 2020.

Italy simplifies over-the-counter generics price and reimbursement

Home/Policies & Legislation | Posted 26/03/2021

The Italian Drugs and Medicines Agency (Agenzia Italiana del Farmaco, AIFA) has simplified its price and reimbursement procedure for class C generic/biosimilar medicines. As of February 2021, generic/biosimilar versions of over-the-counter class C reference products will automatically be classified as class C products.

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