Biosimilars and recombinant drugs

Authors Avatar by pragsmbagmailcom (student)

1. Biosimilars:

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.

Join now!


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:

  • Patient safety and Immunogenecity:  As biosimilars are not similar to biopharmaceuticals, the potential risk associated with them is also different. Immunogenecity associated with these protein products ...

This is a preview of the whole essay