Biosimilars

Introduction

Emergence of the biotechnology will continue as a major solution of therapeutic to the dangerous diseases recognized to humanity. All across the world, there are few hundreds of medicines of biomedical that helped millions of people (Suh, 2010). Around 45 % to 50 % share is expected to impart by the biomedical drugs in the drug market. According to the claims of scientists, biomedical drugs can treat successfully those serious diseases which appeared to be incurable (Suh, 2010).

Therapeutic products like Monoclonal antibody therapy, gene therapy, Vaccines, recombinant proteins that are created from living organisms in order to treat particular health situations and are formed by biotechnology, these products are known as biomedical products (Suh, 2010). Subsequent copyright expiration of numerous biological drugs in pharmaceutical firms is using to obtain agreement for biosimilar drug. The issue regarding biosimilars has been a serious matter in national debate (Suh, 2010).

Discussion

Biosimilars

Biosimilars is a biotherapeutic manufactured goods which is alike in terms of safety, efficacy and quality to an already approved reference biotherapeutic product (GaBi, 2012). Or in other words, biosimilars is a product based on biotechnology that is verified to be similar to an already accredited reference product in non clinical evaluation, clinical evaluation and quality (Suh, 2010).

Difference between Biosimilars and Generics

A Generic is derived from medicinal product chemically, typically a regular, small homogeneous molecule. However, a biosimilar is such a medicinal product which is formed from biological origin. Typically it has large proteins and complex structure that is related to heterogeneity (GaBi, 2012). In consequence of that heterogeneity, any kind of changes should be considered in order to make sure that there is no therapeutic or healing consequence for the patient. Moreover, the biosimilarity is needed to demonstrate through severe comparisons of safety and efficacy (GaBi, 2012). Hence, the regulatory necessities of the EMA that is the European Medicines Agency for the improvement of biosimilars are much more challenging as compared to rising generics (GaBi, 2012).

Approved biosimilars

In the year 2003, biosimilars were approved in the legal framework in the EU. Biosimilars can be certified and licensed via only EMA in this framework (GaBi, 2012).

Guidelines were developed by EMA during the period of 2005 and 2006 for the purpose of approving biosimilars through a registration process.

In the EU, somatropin (Omnitrope) was the primary product that was approved as a biosimilar in the year 2006 (GaBi, 2012). So far, EMA has agreed around 14 biosimilars inside the product classes of granulocyte colony-stimulating factor, erythropoietin and human growth hormone for usage in the EU. Below is the list of approved biosimilars (GaBi, 2012).

Product name

Therapeutic area

Company name or manufacturer name

Active substance

Date of authorization

Binocrit

Chronic kidney failure and Anaemia

Sandoz GmbH

epoetin alfa

28 Aug 2007

Abseamed

Cancer, Anaemia and chronic kidney failure

Medice Arzneimittel Pütter GmbH & Co KG

epoetin alfa

28 Aug 2007

Biograstim

cell transplantation, Haematopoietic stem, cancer and Neutropenia

CT Arzneimittel GmbH

filgrastim

15 Sep 2008

Filgrastim Hexal

cell transplantation, Haematopoietic stem, cancer and Neutropenia

Hexal AG

filgrastim

6 Feb 2009

Epoetin alfa Hexal

Chronic kidney failure, cancer and Anaemia

Hexal AG

epoetin alfa

28 Aug 2007

Filgrastim ratiopharm

cell transplantation, Haematopoietic stem, cancer ...