GenericsWeb Exposes Differences Between Abatacept Generic Launch Contraints in EU and US, and Highlights the Need for an Established Route for Biogenerics

Share Article

GenericsWeb reveals that the lack of a legislated approval route and data exclusivity period for biogenerics in the US leaves generic developers of Abatacept products wondering how and when they may file for FDA approval of a biogeneric, and when they might expect to be in a position to launch.

GenericsWeb, the leader in established pharmaceutical patent analysis and searching, recently published an article that analysed opportunities in launching a generic version of Abatacept. Based on its proprietary Pipeline Patent Intelligence GenericsWeb reveals that the lack of a legislated approval route and data exclusivity period for biogenerics in the US leaves generic developers of Abatacept products wondering how and when they may file for FDA approval of a biogeneric, and when they might expect to be in a position to launch. This is contrasted with the position in the EU where the regulatory pathway and data exclusivity protection is clear, but the Orencia indications are protected by much later 'use' patents, whose expiry is not uniform across the region due to the sporadic use of SPC extensions in some member states.

Orencia® (Abatacept), marketed by Bristol Myers Squibb, is indicated for the treatment of adult rheumatoid arthritis and juvenile idiopathic arthritis in patient who have experienced an inadequate response to disease modifying anti-rheumatic drugs (DMARDs).Being one of the few authorised fusion protein drugs on the market, increased attention is being paid to Orencia® with a view to launching bioequivalent products in the future.

The article expresses a particular concern in developing a biogeneric version of Orencia as being the uncertainty in relation to approval legislation including the applicable data exclusivity period for biologic drugs in US. "This is rather problematic when planning generic development of a biologic since proposals range from 5 to 14 years data exclusivity and could significantly affect the generic launch date," said John He, patent analyst at GenericsWeb. "As a worst case scenario, potential filers for an Orencia bioequivalent product could be looking at an earliest filing date of December 2019, resulting in possible approval anywhere from 2021 onwards."

The article also discusses barriers for developing a generic Abatacept product in the EU and identifies a patent family that appears to be a major obstacle for developing a generic Abatacept product in Europe where it protects the sole indicated use, since the expiry dates are much later than those of other patents protecting the Abatacept molecule and are subject to granted SPC extensions in some countries. The author further analysed the protection of the corresponding US patent stating that due to the difference in approved indications "it is arguable that the claims of US 7,455,835 do not protect the indicated use.

"The two issues of a lack of a Biogeneric pathway in the US and non-harmonisation of EU patent expiry dates highlighted in this article are frequently discussed topics in the industry" commented GenericsWeb CEO Leighton Howard. "The particular case of Abatacept highlights the urgency in passing appropriate legislation to allow the generic pharmaceutical industry to effectively plan and develop generic products with certainty of returns on their investment, so that they may continue to contribute to reducing the cost of healthcare around the world."

You can read the entire article here at http://www.genericsweb.com/druginfocus/abatacept/

ABOUT GENERICSWEB - THE SEARCH IS OVER
GenericsWeb, the leader in pharmaceutical patent analysis and searching holds an impeccable track record in providing quality patent information, and has allowed numerous pharmaceutical companies to successfully navigate intellectual property hazards. GenericsWeb is headquartered in Sydney, Australia, with offices in North America and Europe. All staff are highly skilled and experienced internationally and have extensive experience in pharmaceutical sciences and patent searching. For more information, visit the company's web site at http://www.genericsweb.com.

PIPELINE DEVELOPER
Pipeline Developer, a professional patent database providing the very best in comprehensive patent information while minimising the risk of wasted developments or legal action. Searched and analysed by highly trained, dedicated staff using sophisticated searching techniques, Pipeline Developer delivers results you can rely on through a convenient online interface. For more information on Pipeline Developer visit http://www.genericsweb.com.

###

Share article on social media or email:

View article via:

Pdf Print

Contact Author

Zac Kardiasmenos
GenercisWeb
+61 (0)2 9262 7696
Email >
Visit website