Biosimilar therapeutics—what do we need to consider?

نویسنده

  • Huub Schellekens
چکیده

Patents for the first generation of approved biopharmaceuticals have either expired or are about to expire. Thus the market is opening for generic versions, referred to as 'biosimilars' (European Union) or 'follow-on protein products' (United States). Healthcare professionals need to understand the critical issues surrounding the use of biosimilars to make informed treatment decisions.The complex high-molecular-weight three-dimensional structures of biopharmaceuticals, their heterogeneity and dependence on production in living cells makes them different from classical chemical drugs. Current analytical methods cannot characterize these complex molecules sufficiently to confirm structural equivalence with reference molecules. Verification of the similarity of biosimilars to innovator biopharmaceuticals remains a key challenge. Furthermore, a critical safety issue, the immunogenicity of biopharmaceuticals, has been highlighted in recent years, confirming a need for comprehensive immunogenicity testing prior to approval and extended post-marketing surveillance.Biosimilars present a new set of challenges for regulatory authorities when compared with conventional generics. While the demonstration of a pharmacokinetic similarity is sufficient for conventional, small-molecule generic agents, a number of issues will make the approval of biosimilars more complicated. Documents recently published by the European Medicines Agency (EMEA) outlining requirements for the market approval of biosimilars provide much-needed guidance. The EMEA has approved a number of biosimilar products in a scientifically rigorous and balanced process. Outstanding issues include the interchangeability of biosimilars and innovator products, the possible need for unique naming to differentiate the various biopharmaceutical products, and more comprehensive labelling for biosimilars to include relevant clinical data.

برای دانلود متن کامل این مقاله و بیش از 32 میلیون مقاله دیگر ابتدا ثبت نام کنید

ثبت نام

اگر عضو سایت هستید لطفا وارد حساب کاربری خود شوید

منابع مشابه

What do oncologists need to know about biosimilar products?

Many biologic products have improved the outcomes of cancer patients, but the costs can substantially burden healthcare systems. Biosimilar products can potentially reduce drug costs and increase patient access to beneficial treatments. Approval of a biosimilar product relies on the demonstration of "comparability" or "no clinically meaningful differences" as compared to its reference biologic ...

متن کامل

High Stakes Require More Than Just Talk: What to Do About Corruption in Health Systems; Comment on “We Need to Talk About Corruption in Health Systems”

Reluctance to talk about corruption is an important barrier to action. Yet the stakes of not addressing corruption in the health sector are higher than ever. Corruption includes wrongdoing by individuals, but it is also a problem of weak institutions captured by political interests, and underfunded, unreliable administrative systems and healthcare delivery models. We ur...

متن کامل

Diagnostic and therapeutic challenges for dermatologists: What shall we do when we don’t know what to do?

What shall we do when we have done everything we could for the diagnosis and treatment of a patient, but were not successful? What shall we do when there is no definite treatment for a patient? What shall we do when we have no diagnosis or treatment for a patient? Some useful suggestions are presented here to get rid of these situations.

متن کامل

The future role of natural products in health care

For thousands of years, one of our many gifts from the Earth has been medicines to treat a myriad of ailments. In the developed world, approximately 25% of prescription products are derived from higher plants, and in the developing world, over 80% of the population relies on plants, in the form of traditional medicine, for their primary health care. In 2050, the Earth will have a population of ...

متن کامل

The future role of natural products in health care

For thousands of years, one of our many gifts from the Earth has been medicines to treat a myriad of ailments. In the developed world, approximately 25% of prescription products are derived from higher plants, and in the developing world, over 80% of the population relies on plants, in the form of traditional medicine, for their primary health care. In 2050, the Earth will have a population of ...

متن کامل

ذخیره در منابع من


  با ذخیره ی این منبع در منابع من، دسترسی به آن را برای استفاده های بعدی آسان تر کنید

برای دانلود متن کامل این مقاله و بیش از 32 میلیون مقاله دیگر ابتدا ثبت نام کنید

ثبت نام

اگر عضو سایت هستید لطفا وارد حساب کاربری خود شوید

عنوان ژورنال:

دوره 2  شماره 

صفحات  -

تاریخ انتشار 2009