Industry Trends

March was a busy month for makers of generics and biologics, with several bills being introduced in the 111th Congress proposing new legislations on generics and biosimilars. While these bills are making the rounds in committee reviews, responses from industry stakeholders run the gamut from bipartisan support to partisan rejection, with few surprises.

Thanks to biologics, cancer is becoming not only a more chronic disease but also a resoundingly expensive one. In this economic climate, the financial framework for cancer care is headed for change, but how? At a recent webinar sponsored by Oncology Business Review (www.oncbiz.com), opinion leaders discussed the challenges and the options for meeting them.
 

If March 2010 was any indication for the US Food and Drug Administration (FDA)'s intentions, 2010 will witness a good number of generic approvals. Compared with the meager approval record in January (1) and February (2), by March 23 the FDA approved 15 generics in that month alone.

The Generic Pharmaceutical Association (GPhA) recently praised the Obama administration's fiscal 2011 budget proposal for the US Food and Drug Administration (FDA), which will increase the FDA's Office of Generic Drugs to $51.5 million, a $10-million increase compared with fiscal year 2010.1 In supporting the administration's attempt to strengthen access to generics, GPhA's President Kathleen Jaeger noted, "Generics also save our health care system money, a critical factor in these difficult economic times.

The most important scientific investigations in breast cancer are presented each year at the San Antonio Breast Cancer Symposium (SABCS). In its December 2009 meeting, several trends emerged, with strong implications to patient management and direct relevance to payers, patients, and providers.

Bisphosphonates: Not Just for Bone Loss Anymore

Several promising compounds for the treatment of rheumatoid diseases have been recently approved, are in phase 3 trials, or are about to undergo phase 3 evaluation. The following products are some of the main products that were featured at the 2009 annual meeting of the American College of Rheumatology (ACR).

Promising Therapies for Lupus, Gout, and More

Several new drugs developed for the treatment of a variety of cardiovascular diseases are currently in the pharmaceutical pipeline. The following findings were presented at the 2009 annual meeting of the American Heart Association (AHA).

Antiplatelet Agents in Pipeline Pitted against Clopidogrel

As 2009 is coming to a close, the future of generics appears brighter than ever, with many brand-name medications pending patent expiration by 2011, accounting for about $34 billion in total sales in 2008.1 The drug patent expiration outlook overshadows the recent Senate vote to extend the patent exclusivity period for biologics to 12 years, as requested by the biotechnology industry, thereby significantly delaying the introduction of potential biosimilars to the market. A biosimilars pathway now seems likely to become a reality by 2010 or 2011.

Now that gene tests, markers for tumor receptors, assays for rapid and precise diagnosis of infectious agents, and a variety of other molecular probes have created an entirely new world of personalized medicine, it is time to add new information management tools to capture and manage this knowledge.

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  •  Association for Value-Based Cancer Care
  • Oncology Practice Management
  • Value-Based Cancer Care
  • Value-Based Care in Rheumatology
  • Rheumatology Practice Management
  • Urology Practice Management
  • Lynx CME