Welcome to our new website! If this is the first time you are logging in on the new site, you will need to reset your password. Please contact us at raps@raps.org if you need assistance.
The site navigation utilizes arrow, enter, escape, and space bar key commands. Left and right arrows move across top level links and expand / close menus in sub levels. Up and Down arrows will open main level menus and toggle through sub tier links. Enter and space open menus and escape closes them as well. Tab will move on to the next part of the site rather than go through menu items.
The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.
Share your knowledge and expertise with your regulatory peers by submitting an in-depth, evidence-based article focusing on key areas and emerging issues in the global regulatory landscape.
One of our most valuable contributions to the profession is the Regulatory Code of Ethics. The Code of Ethics provides regulatory professionals with core values that hold them to the highest standards of professional conduct.
Your membership opens the door to free learning resources on demand. Check out the Member Knowledge Center for free webcasts, publications and online courses.
Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.
RAPS Euro Convergence brings regulatory peers from the EU and worldwide together in one forum to gain insights and exchange ideas on the region's most pressing issues. Register today to attend 10-12 May 2021.
Registration is now open for RAPS Convergence 2021! Gather with the regulatory community 12-15 September for four days of learning, engagement, and excitement.
With contributions from more than 30 authors from seven countries, the new edition incorporates a global overview of the field and is designed to help you get the most out of your regulatory intelligence endeavors.
Regipedia is an interactive resource created to benefit RAPS members with 24/7 access to more than 2,300 regulatory terms.
Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
The RAPS store will be under maintenance Saturday, 17 April between 5 AM and 12 PM EST. Store functionality may be unavailable at times during this window. We apologize for any inconvenience caused during this time.
Posted 05 March 2015 | By Alexander Gaffney, RAC,
The US Food and Drug Administration (FDA) quietly confirmed last week that it planned to release its long-sought biosimilars labeling guidance document sometime in 2015. But with the agency expected to approve the US' first biosimilar, Sandoz' Zarxio (filgrastim, EP2006), as early as tomorrow (6 March 2015), there's a good chance the biopharmaceutical industry won't have to wait long for the release of that guidance.
At issue is the nomenclature system by which biosimilar products will be named.
Currently, both branded and generic chemical drugs share the same nonproprietary name, also known as its International Nonproprietary Name (INN). For example, both Advil and its generics are both known by the chemical name ibuprofen. This is meant to allow healthcare practitioners to readily assess which drug products are substitutable for one another in clinical practice.
But for biosimilar products, there's a problem. Unlike chemically derived generic drugs, which are supposed to be chemically identical to the drug they reference, it is all but impossible for biosimilar drugs to be identical to the approved biologic they reference. That’s because each product is derived from slightly different cell lines and is produced using slightly different manufacturing processes. While the ultimate products are highly similar, and may even have the same effect on patients, they are nevertheless not identical.
And for some industry and patient groups, those differences are potentially concerning. Those minor differences, they say, could mean biosimilar products cause different adverse events in consumers. If biosimilars share the same INN with their reference biologics, pharmacovigilance—the practice of surveillance after a drug is approved—could be made more difficult for regulators, who might not recognize which product is causing a problem. The groups have argued that each biosimilar should have its own distinct nonproprietary name.
On the opposite side are some public advocacy groups and generics companies, who have argued the issue is a distraction. FDA is the ultimate arbiter of product safety, they say, and attempts to change the names of the products are in part intended to scare or confuse consumers about the quality of new biosimilar drugs.
A third, more mainstream view is that biosimilar products should adopt the nonproprietary name associated with the reference product, but also be accompanied by a short code—ZAR, for example—to allow for easier pharmacovigilance reporting.
Everyone, it seems, has weighed in on the issue—with the exception of FDA, that is.
But that could be about to change as early as this week. In August 2014, FDA accepted the first-ever biosimilars application (using the 351(k) pathway established under the AffordableCare Act) for approval in the US. The drug, Sandoz's monoclonal antibody Zarxio, is a biosimilar version of Amgen's Neupogen (filgrastrim).
The drug is somewhat unusual in that it has already been approved by several major global regulators, including the European Medicines Agency, Japan's Pharmaceuticals and Medical Devices Agency (PMDA) and Health Canada. That approval history has given Sandoz a wealth of data with which to placate FDA, which has taken to the drug favorably.
On 7 January 2015, an FDA advisory committee voted 14-0 in favor of approving the drug, all but assuring FDA regulators will do the same.
With FDA set to reach an approval decision on Zarxio on 8 March 2015—the company's biosimilar drug user fee date—it seems likely that the agency will accompany any biosimilar approval decision with the release of its biosimilars labeling guidance.
When asked about the expected timing of the guidance, FDA spokeswoman Sandy Walsh said only that she did not "have any update to share at this time."
Still, it's hard to imagine FDA approving a new product without knowing what it will call the product in its own press release or on the drug's label. So if biosimilar labeling issues are your bread and butter, it might behoove you to pay close attention to FDA's website over the next few days.
Tags: Biosimilar, Biosimilar Labeling Guidance, Guidance, Draft Guidance, INN
Regulatory Focus newsletters
All the biggest regulatory news and happenings.