Tuesday, October 19, 2010

Pfizer Makes Move Into Biologic Drugs (NYTimes)

NY Times October 18, 2010, 12:05 pm
Pfizer Makes Move Into Biologic Drugs

Making a new move into the fledgling market for generic biotech drugs, pharmaceutical giant Pfizer has acquired worldwide rights to sell human insulin and insulin analogs being developed by Biocon, one of India’s largest biotech companies. (Read More: http://prescriptions.blogs.nytimes.com/2010/10/18/pfizer-makes-move-into-biologic-drugs/) . . . that since the pathway for biogenerics has not yet been established, Biocon plans to conduct a phase 3 clinical trial of its insulin and to seek approval under an existing pathway known as rule 505(b)(2).

The first biologic for oncology is not coming off the patent protection until 2014.  Herceptin's and Rituxan/MabThera's patents expire in 2014 and 2015 and Avastin is covered till 2017.  The Pfizer’s move leads me to predict that companies will be more inclined to establish their own subsidiaries to manufacture and market “cheaper-priced-branded-drugs” once the patent and FDA protections expire.  The nature of biologics is on their side – biosimilars will be just “similars” not “same” as long as parts of manufacturing are protected under Trade Secrets.

Further Reading:

The biosimilars market today and tomorrow.  By Alan Sheppard BioValley.ch, 1 September 2010.
When Patents Are Not Enough: Data Exclusivity for Follow-On Biologics. By JE Calfee. In:  UNCLE SAM, MD - aei.org 

 The value of patent term extensions to the pharmaceutical industry in the USA.  Journal of Generic Medicines 5, 201-208 (April 2008) | doi | FullText
drug patent protection terms depends on many things, such as, patent term restoration (Hatch-Waxman Act, 1984), and several FDA market exclusivities (orphan drug, pediatric extension, data exclusivity) 
The face of the patent is not the ‘‘Whole Story’’: determining effective life of a pharmaceutical patent in the United States. By Anne Marie Clark and Heidi Berven. World Patent Information 26 (2004) 283–295| doi | GoogleScholar |
describes multiple database searches (free such as USPTO and FDA Orange Book, and fee-base, such as, Dialog, Questel-Orbit, MicroPatent, Delphion, STN, Inpadoc) required for determining drug patent and exclusivity term. Dialog, DrugPatentWatch

Every year (Jan-Feb) Am J Health-Syst Pharm publishes a list and analysis of drugs losing patent and going generic.  For example: Projecting future drug expenditures.  2010 report at Link. 

 Can You Afford Cancer? by: Jo Cavallo. Cure Today, Issue Winter 2008 | Link |
Cancer drug prices in the era of healthcare reform. By Asher J Steene. Future Oncology. May 2010, Vol. 6, No. 5, Pages 647-650 | PubMed | | doi | FreeFullText |

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