Generic biopharmaceuticals

There is an increasing demand from consumers for access to lower-cost biopharmaceuticals and, because drag costs continue to receive increased scrutiny, the timing for generic biopharmaceuticals is excellent, creating an alternative for affordable medications. Many regulatory authorities are in a quandary as to what to do from regulatory and economic standpoints. 

Traditionally, HPLC, GC-MS, or LC-MS methods were used to monitor the clearance of small-molecule impurities. These analytical techniques often require unique solvents, columns, methods, reagents, detectors, and buffers for each analyte to be quantified. The NMR method, albeit not the most sensitive technique, normally does not have these problems. In this chapter, some examples will be used to demonstrate that NMR is a fast, generic, and reliable analytical technique for solving analytical problems encountered in the development of biopharmaceutical products. The NMR techniques described here require minimal sample handling and use simple standard NMR methods. They can easily be implemented and used for process development and validation purposes. 

One aspect in which biopharmaceuticals may differ from small molecule NCEs concerns the ease of generic entry when patents expire. To date, there have only been a few patent... 

This debate is particularly pertinent as some of these first generation biopharmaceuticals produced by rDNA technology are coming off-patent, as shown in Table 10.3, and the generics industry aims to tap into this market, while at the same time regulatory authorities are under pressure to work toward making drugs more affordable to patients. 

In the case of glycoprotein biopharmaceuticals, the consequence of the multiple glycosylated products is the need for strict control of the manufacturing process to maintain a reproducible spectrum of products with consistent therapeutic profile. That biopharmaceuticals often contain mixtures of related products can also be advantageous to the pharmaceutical industry in warding off generic competition, due to the challenge of... 

A major change in the biopharmaceutical industry is the imminent entry of generic firms. Between 2001 and 2006, biopharmaceuticals with a total market of over 13 billion went off patent. 

Polastro E, Little A (2001), When will we see legal generics of top biopharmaceuticals ContractPharma Out. Available at http //www.contractpharma.com/articles/ 2001/10/the-future-of-biogenerics.php (accessed October 2006). 

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