FDA Accepts Apotex's Neupogen Biosimilar Application: Raises Issues of How the Agency Will Address Exclusivity, Previous Warning Letters to Apotex
Apotex Inc. has announced that as of February 13, 2015, the FDA has accepted for filing the company's application for filgrastim, a biosimilar version of Amgen's Neupogen. The product was jointly developed with Intas Pharmaceuticals Ltd. Filgrastim is used to help cancer patients taking chemotherapy to fight infections and fever by boosting white blood cell count. This is the fifth application submitted through the 351(k) abbreviated approval pathway created by the Biosimilar Price Competition and Innovation Act (BPCIA), and the second biosimilar submitted by Apotex.
This latest Neupogen biosimilar application is not...
Source: Policy and Medicine - February 19, 2015 Category: American Health Authors: Thomas Sullivan Source Type: blogs
FDA’s CDER and CDRH Release 2015 Guidance Agenda and Comprehensive Document Search Tool
The Food and Drug Administration seems poised for a busy 2015. The Agency’s Center for Drug Evaluation and Research (CDER) just released their annual guidance document agenda for 2015. They intend to publish 90 guidance documents this year, including several aimed at advertising, biosimilars, pharmaceutical quality and manufacturing standards, and the Drug Supply Chain Security Act. The Center for Devices and Radiological Health (CDRH) released their 2015 plan as well--indicating Laboratory Developed Test and software-related guidances are in the works. To cap off a busy new year, FDA also released a well-organized guida...
Source: Policy and Medicine - January 14, 2015 Category: American Health Authors: Thomas Sullivan Source Type: blogs
Biosimilars Update: FDA Staff Recommends Approval of First Biosimilar in U.S.; Agency Accepts Third Biosimilar Application For Review
FDA’s “Purple Book,” which lists all licensed biological products, currently has an empty column under the “biosimilar” heading, which would state imitation products deemed “highly similar” next to the listed reference. That may change soon. Tomorrow, the FDA will consider whether the Agency should approve Novartis AG's copy of Neupogen, Amgen Inc.'s successful injectable biologic used to prevent infection in patients on chemo therapy. FDA staff reviewers recommended approval for the copy on all five of its proposed indications yesterday.
View the FDA Briefing Document in advance of the Oncologic Drugs...
Source: Policy and Medicine - January 6, 2015 Category: American Health Authors: Thomas Sullivan Source Type: blogs
Battle Lines Drawn Over Biosimilar Application And Patent Disclosure Process
The Biosimilars Price Competition and Innovation Act of 2009 (BPCIA) introduced a long-awaited, and highly-supported, abbreviated route to market for “biosimilar” and “interchangeable” biologic products. The goal was to create incentives for development and reduce health care costs in the same way that previous legislation had accomplished in the generic arena over three decades ago.
However, widespread criticism of BPCIA provisions to facilitate interactions between biosimilar applicants and reference biologic sponsors regarding application submission and patent status was swift and unrelenting. Attorneys practici...
Source: Health Affairs Blog - November 17, 2014 Category: Health Management Authors: Jordan Paradise Tags: All Categories Bioethics Biotech Pharma Research Science and Health Source Type: blogs
Courting Biosimilars
In the first lawsuit filed by an originator company over a biosimilars application, Amgen alleged that Sandoz has unlawfully refused to follow the patent resolution protocol laid out by the Biologics Price Competition and Innovation Act of 2009 (BPCIA).
The suit, filed in the U.S. District Court for the Northern District of California, concerns Sandoz's application to market a biosimilar version of Amgen's Neupogen filgrastim G-CSF, a recombinant methionyl human granulocyte colony-stimulating factor.
Under BPCIA, Sandoz was required to provide Amgen with its BLA and manufacturing information for the biosimilar within ...
Source: drugwonks.com Blog - October 31, 2014 Category: Pharmaceuticals Source Type: blogs
Biosimilars Update: FDA Releases “Purple Book”; Two Companies File Biosimilar Applications, Industry Responds to Draft Guidance
Vaccines, allergy shots, blood components, and gene therapies are examples of biological products. Most biologics are produced in living organisms, such as plant or animal cells, whereas small molecule drugs (most pharmaceuticals) are typically manufactured through chemical synthesis. The inherently complex nature of biologics makes them expensive to develop and impossible to copy in the manner traditionally associated with the approval of generic drugs.
BioSIMILAR, not BioEQUIVALENT
Enter “biosimilars,” which the Food and Drug Administration (FDA) defines as biological products that are highly similar to an already ap...
Source: Policy and Medicine - September 15, 2014 Category: American Health Authors: Thomas Sullivan Source Type: blogs
Delete Blood Cancer: What You May Not Know About Bone Marrow Donation
We all know about blood drives and the importance of blood and platelet donations to save lives. And millions of people are registered organ donors (usually when they get their driver’s license). But did you know that there is another renewable, life-saving resource you could give? It’s your blood stem cells/bone marrow. Only 11 million Americans are registered with the National Marrow Donor Program to help save lives if their blood stem cells match a person fighting any one of 70 blood cancers and diseases.
Each year, nearly 20,000 people are in need of blood stem cell/bone marrow transplants as their last hope for ...
Source: Disruptive Women in Health Care - July 22, 2014 Category: Consumer Health News Authors: DW Staff Tags: Access Advocacy Cancer Consumer Health Care Patients Publc Health Source Type: blogs
Amgen CEOs Prosper Despite (or Because of) Continuing Ethical Questions
This is becoming a familiar narrative on Health Care Renewal: top health care leaders continue to enrich themselves while their organizations' behavior continues to raise ethical questions.For our latest example we return to the ongoing adventures of biotechnology giant Amgen.CEOs Get Richer An AP story (via the LA Times) documented the continuing enrichment of its current CEO:Amgen Inc's new chief executive, Robert A. Bradway, received total compensation of $13.6 million in 2012, more than his predecessor, according to an analysis of a company regulatory filing.Bradway, who was promoted from chief operating officer to ...
Source: Health Care Renewal - May 2, 2013 Category: Health Medicine and Bioethics Commentators Tags: Amgen executive compensation kickbacks legal settlements adverse effects Source Type: blogs
2012: Banner Year for New Drugs
Fueled by new cancer therapeutics, last year the annual new molecular and biological entity approval count from the U.S. Food and Drug Administration (FDA) saw its highest year since 1997. One-third of the novel products approved by the FDA’s Center for Drug Evaluation and Research (CDER) are used to treat cancers of the blood, breast, colon, prostate, skin and thyroid.
As part of the U.S. Food and Drug Administration (FDA), the Center for Drug Evaluation and Research (CDER) promotes and protects the health of Americans by assuring that all prescription and over-the-counter drugs are safe and effective. The CDE...
Source: Highlight HEALTH - February 13, 2013 Category: Medical Scientists Authors: Walter Jessen, Ph.D. Source Type: blogs
Biosimilars and Off-Label Communication
Considering the paucity of biosimilar-specific data on the label for Sandoz’s filgrastim-sndz biosimilar, should sponsors be able to discuss their products’ analytical and clinical data with health care providers and payers? And what about with physicians? When it comes to biosimilars, is off-label now on the table (Source: drugwonks.com Blog)
Source: drugwonks.com Blog - September 6, 2007 Category: Pharmaceuticals Source Type: blogs
BioBummer
The FDA has decided to postpone the March 17th meeting of the Arthritis Advisory Committee. The adcomm was supposed to discuss Celltrion’s infliximab biosimilar application. The Pink Sheet proclaimed this a “Biosimilar Bummer.” A bummer for Celltrion to be sure, but the lesson to be learned is that the filgrastim adcomm, viewed by many as a FDA love-fest should not be viewed as a broader predictive regulatory response to every biosimilar application. Many saw it as such because they wanted it to be true. Bummer? Not if you understand that the decision tree for biosimilars is quite different from the Hatch-Waxman path...
Source: drugwonks.com Blog - September 6, 2007 Category: Pharmaceuticals Source Type: blogs
Suffix is in
Instead of calling Zarxio simply filgrastim -- the desire of those who believe differential nomenclature is the devil incarnate,the FDA has dubbed the new product filgrastim-sndz, the suffix standing for Sandoz. (Source: drugwonks.com Blog)
Source: drugwonks.com Blog - September 6, 2007 Category: Pharmaceuticals Source Type: blogs
Filgrastim -- and then what happens?
Welcome Zarxio. While nothing is “easy” when it comes to drug development, many view this initial Sandoz experience as forecasting clear skies and fair winds for every biosimilar put in front of the agency for consideration. If you believe that, there’s a bridge in Brooklyn you might find of interest. (Source: drugwonks.com Blog)
Source: drugwonks.com Blog - September 6, 2007 Category: Pharmaceuticals Source Type: blogs
Fil in the blanks
The filgrastim adcomm isn’t the end of the debate. There are still many issues yet to be determined via FDA guidance (such as nomenclature) and corporate strategy (read, “pricing”). As BIO’s Jim Greenwood said, “This week’s advisory committee meetings facilitated important discussion of the scientific approach of reviewing biosimilar applications and we encourage this positive momentum, however, we believe the appropriate way to develop policy on such a significant new approval pathway is through published guidance documents with the opportunity for public comment, rather than through single-application adviso...
Source: drugwonks.com Blog - September 6, 2007 Category: Pharmaceuticals Source Type: blogs
