Biopharmaceuticals are defined as protein drugs synthesized by recombinant biotechnology with the use of bacteria, virus, plant and animal cells. Biopharmaceuticals have created miracles in disease treatment since the time they have been launched and created wonders in the treatment of diseases which had no remedy earlier example orphan diseases (Nowicki, 2007). Biopharmaceuticals have been in use vastly since their emergence however, the expiration date of these drugs has become a huge concern in medical care.
Biosimilars (In Europe) or Follow-on biologics (In USA) are biopharmaceuticals which resemble biopharmaceuticals in their activity, but differ in the physical and chemical properties. They are considered to be the cheaper versions of biopharmaceuticals and claimed to be tested to elicit similar biological activities as that of original biopharmaceuticals (Covic and Kuhlmann, 2007). Some of the first examples of Biosimilars available in the market include Omnitrope, biosimilar to Genotropin and Valtropin which is biosimilar to Humatrope (Nau, 2006; Burger, 2006).
There are many Biosimilars being developed in the market which are waiting to be approved. POTENTIAL MERITS AND DEMERITS OF BIOSIMILARS: MERITS: Biosimilars had come as a boon to the biologists when there was a concern of biopharmaceuticals patent expiration. They are cheaper versions eliciting the same biological effects as that of original biopharmaceuticals. They help in treatment of many orphan diseases. DEMERITS: Biosimilars are not identical with biopharmaceuticals in structure, manufacturing and purification.
There are many potential problems identified with Biosimilars which include: Clinical, ethical sense in covering drugs: Many drugs are treated the same way regardless of the activity it provides. For example Avastin did not show any improvement in patient condition but another adjuvant drug Herceptin, decreased deaths due to breast cancer. Both of these drugs are treated the same way, which decreases cost effectiveness (Thomas et al., 2008).
INCREASING COSTS OF RECOMBINANT DRUGS: The use and value of recombinant drugs is increasing day to day, and health agencies in UK and USA have responded tremendously to this. Recombinant drugs and their variants are becoming extremely expensive and has become a challenge to both the governments. Keeping pace with the growing technology and health care needs has become a challenge to both the governments (Peter and Philips, 2007).
To address the situation, US government has strategically improved its health care plans in investing funds for research and development organizations for inventing follow on biologicals. This approach would be cost effective and rightly address the problem. Apart from initial funding, US and UK governments are planning to support more in further research of their improvement (Peter and Philips, 2007).
Another significant development by medicare is pay for performance to increase health care standards where money is paid according to performance shown (Alan et al. , 2008).
1. Michal,N. (2007) Basic Facts about Biosimilars. Kidney Blood Press Res . 230, pp. 267–272. 2. Nau, J. Y. (2006) Omnitrope, first ‘biosimilar’ drug of the European Union. Rev Med Suisse. 2, pp. 1206. 3. Thomas, H. , Lee, M. ,Ezekiel, J. , Emanuel, M. (2008) Tier 4 Drugs and the Fraying of the Social Compact. Engl j med . 359, pp. 4.