More complex generics will be approved in more often in the future

At Forbes, they recently talked with Jeffrey George, global head of Novartis's Sandoz generic drug unit. Upon the approval of the generic for Lovenex, George believes that it has opened the pathway for other complex generics to be approved in the future. While the drug is not a generic, it has a complex sugar structure that is hard to copy.

George commented, "It underscores that the FDA really does have the institutional courage to approve affordable high quality alternatives to some of the more difficult to make products that are out there. There were a lot of interests lined up against this approval. It bodes well for the approval of more complex generic products in the future."

Share this article with your social network, just click below to share now!

Share |

FDA approves first biosimilar

On Friday, the FDA announced its approval for the generic blood thinner Sanofi Aventis blood thinner Lovenox. This highly complex drug is the first and now sets a pathway for other generic copies of proteins to be approved. Due to the complexity of these molecules and how they are copied, there is still debate about how many safety trials should be conducted. (Source: The Great Beyond)

On Monday, Sanofi Aventis asked the US Court to withdraw it's approval on the drug, believing that they may have not tested for the same active ingredient in Levenox. They also stated in the papers they took to court:

"If not remedied, FDA's decision will cause Sanofi-Aventis irreparable harm and may result in entry into the market of a generic product that is not clinically equivalent to Lovenox with respect to safety or efficacy," Sanofi said in court papers.

Read more about Sanofi's request at Reuters.

Share this article with your social network, just click below to share now!

Share |

Biosimilars White Paper: Panacea or Poison Pill? Making Sense of the New Biosimilars Law

I recently came across the BNA, Inc. white paper "Panacea or Poison Pill? Making Sense of the New Biosimilars Law." It takes an in-depth look at the new healthcare reform that allows the streamline development and FDA approval pathway for biosimilars.

According to the paper:

This article provides a brief overview of the history leading up to passage of the Biosimilar Act, discusses in detail both the FDA regulatory and patent litigation provisions of the act (with comparisons and contrasts to the Hatch-Waxman scheme), probes potential interpretations of key provisions, and offers practical strategic considerations both for companies seeking to pursue product approvals under the new law, and for companies whose products now may face increased competition from follow-on products.

Read the white paper here.

Share this article with your social network, just click below to share now!

Share |