Drug Information and Comparison

Biosimilar Medicines or Biosimilars

Biotechnology has emerged, and will emerging, as major therapeutic solution to many most dangerous diseases known to humankind. Just few hundreds biomedical medicines have helped millions of people across the world. Biomedical drugs are expected to impart 45%-50% share in drug market. As scientists claim, serious diseases which are incurable till now can successfully be treated with Biotechnological drugs.

Therapeutic products, such as gene therapy; Monoclonal antibody therapy; recombinant proteins; vaccines, that are developed from living organisms to treat certain health conditions and are produced by biotechnology are called biomedical products. Following patent expiration of several biological drugs pharmaceutical firms are applying to acquire approval for biosimilar drug. This has become issue of grave concern in national debate.

What are Biosimilars or Biosimilar drugs?

Drugs developed from living things, such as human cells; proteins; antibodies, intended to produce therapeutic effects are known as biologics or biomedical drugs. Biologic drug too can be protected with patent which allows producer company to enjoy rights of exclusive production for 20 years. After the patent expires other companies may start production of similar drug. These similar drugs are known as biosimilars or follow-on drugs.

Why Biosimilar and not Generic?

Major hurdle for biosimilar manufacturers is they don\\\'t have access to cell bank, molecular blueprint and data of manufacturing, purification and exact fermentation process that were used to develop original drug. Also, two cell lines developed independently can not be exactly identical to each other. This makes things tougher for biosimilar producers to develop exact copy of original biologic. Taking that fact into consideration European Medicines Agency (EMEA) coined a new term - \\\'Biosimilars\\\'. The term \\\'Biosimilars\\\' denotes that drug is similar but not the copy of existing original drug.

How Biologics are different from Traditional Chemical drugs?

Biologics are different in many ways from traditional chemical centric medicines. Molecules of biologics are larger, with more complex structure and diverse in nature as compare to molecules of chemical drugs. Biologics are made up of organic matters rather than chemicals. Manufacturing of biosimilar drug includes 210 tests while, on the other hand, chemical drug has to pass through 60-70 tests.

The processes used to develop biologic are all critical and complicated and have significant impact on final drug.

Regulatory Approval Pathway For Biosimilar

Time period after which other companies are allowed to legally produce biosimilar drug was earlier 20 years. The health senate accepted proposal by senators Kay Hagan (D-NC), Michael Enzi (R-WY), Orrin Hatch (R-UT) and Anna Eshoo (D-CA)\\\'s bill wherein proposed time period of data exclusivity for original biologics is 12 years. That means no other company can produce biosimilar of the biologic developed by pioneer biologic.

Other proposed exclusivity time periods were.....

• 14 years by Biotechnology Industry Organization (BIO).
• Seven years of exclusivity by senator Sherrod Brown (D-OH)\\\'s bill
• Five years if exclusivity by Senator Charles Schumer (D-NY)\\\'s
• and Nine-years exclusivity period by senator Edward Kennedy (D-MA)

Shorter time period had sparked controversies as many believed that shorter protection time would adversely affect biotech\\\'s capability to develop biomedicines that requires investment of multi-million dollars.

USA FDA has lately allowed pharmaceutical firms to produce biosimilar drugs. Teva is developing biosimilar of Rituxan

Artticle is Courtesy of DrugsInfoCom.com