Roche position on biosimilars is updated

September 3, 2014 11:28 AM

Swiss Pharma giant Roche, recently updated and published their position about biosimilars on their website.

The company states that, the biosimilars became more of a reality globally but several questions remain. While regulatory bodies are getting their heads around developing clear-cut rules to ensure the safe introduction of biosimilar monoclonal antibodies, some countries are already seeing the first of these medicines enter the market, the company says.

Globally, there are many emerging countries in the process of developing or implementing regulatory pathways for the approval of biosimilars, using the WHO guidance document as a reference. “One of the most recent developments is that the Chinese regulatory agency has communicated their intent to engage with key stakeholders and develop a local pathway for the approval of biosimilars,” says Fermín Ruiz de Erenchun, Global Head Biologic Strategy Team at Roche.

“The challenge for many of these countries,” he adds, “will be the implementation and adaptation of the guidelines to the local situation. We still need to see a further convergence on this issue.”

The naming of biosimilars and biotherapeutics in general is another topic that has over the past couple of years received the attention of the WHO and regulatory agencies. This has been intensely debated in several fora, and Roche also attended the open meeting organized by the WHO to explore whether or not such products be allowed to use the same International Nonproprietary Name (INN) as the innovator product.

“Patient safety is of paramount importance. So Roche (and other companies) believe that all biopharmaceutical medicines need to be identifiable throughout the prescribing and dispensing processes, a practice that would not be possible under the current INN system if biosmilars were to use the same INN as the innovator product,” stresses Fermín. He states that a unique and universally available identifier system could ensure that all approved biopharmaceutical medicines are individually identifiable.

The WHO has also recently issued a draft document on Regulatory Expectations and Risk Assessment for Biotherapeutic Products that specifically addresses biopharmaceutical products which have been approved in markets that have either no biosimilar guidelines, or that do not necessarily meet the global recommendations issued in 2010.

Roche position
“Roche has demonstrated that the best way to improve the outlook for patients is to keep developing innovative medicines and diagnostics. Today, we have developed nine innovative cancer medicines which have been proven to improve and, in many cases, extend the lives of people with 12 common cancer types,” comments Fermín.

According to him, “The availability of biosimilar medicinal products enhances competition, and their availability could offer potential economic benefit to healthcare systems while addressing the issue of new treatment options brought about by advances in medical science. However, whether approved biopharmaceuticals or non-comparable biologics patient safety must be the first priority for all products.”

“This assurance can only be had when products have been subject to thorough and extensive analytical, non-clinical and clinical comparative assessments and if there are well, regulated processes in place. It is our strong belief that biosimilar regulations should not impede, but instead promote and provide an incentive for innovative research towards new medicines,” Fermín says.


Source: Roche


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