The workshop will focus on how state regulations and so-called naming conventions may impact the development of, and competition for, follow-on biologics
Baxter will make an upfront cash payment of $33 million to Momenta related to the collaboration for as many as six follow-on biologic
Because Big Pharma has unique advantages compared with generic companies regarding the ability to successfully compete in the follow-on biologics
arena, namely existing manufacturing capabilities, funding, experience with clinical trials and physician detailing, it makes sense that Big Pharma companies would consider the opportunity.
However, even if legislation enabling a follow-on biologics
pathway had passed, it would take several years before practicing physicians had the opportunity to prescribe the generics, noted Dr.
During that time, the agency has worked to sort out scientific issues relating to follow-on biologics
, and a historical white paper and guidance documents on the subject are under development.
There is great demand for lower-cost biological drugs: commercial and regulatory developments will make biosimilars and follow-on biologics
a success - our new report explains how
Insmed's follow-on biologics
portfolio includes INS-19, an investigational recombinant granulocyte-colony stimulating factor (G-CSF) in Phase III trials for the prevention of infections in cancer patients receiving chemotherapy, and INS-20, a pegylated recombinant G-CSF designed to allow for less frequent dosing, that is currently in Phase I trials.
The draft guidance is also expected to address the extent to which applications for follow-on biologics
can reference studies conducted by the manufacturer of the source biologic.
While the FDA has an excellent track record ensuring the safety of generic drugs, scientists at the agency are far more cautious about follow-on biologics
Any discussion regarding the development of a pathway for follow-on biologics
must focus on the facts and seek to protect patient safety and incentives for continued biomedical innovation," said BIO President and CEO Jim Greenwood.
The scientific, legal and regulatory issues involved in creating any approval pathway for follow-on biologics
are complicated," stated Jim Greenwood, president and CEO of BIO.
WASHINGTON -- The Biotechnology Industry Organization (BIO) released today letters which the organization sent to Senators Ted Kennedy (D-MA) and Mike Enzi (R-WY) and to Representatives John Dingell (D-MI) and Joe Barton (R-TX) to lay out a detailed set of key principles which should guide the creation of any statutory pathway for the approval of follow-on biologics