Biological therapies

§  are recombinant molecules, derived from the genetic sequences of existing living organisms

§  are often similar or identical to proteins produced  by the human body

§  are generally administered by injection

§  have very specific molecular targets (e.g. receptors, cytokines)

Nomenclature: biologics ending with different words have different meaning suggesting source .

•      Monoclonal antibodies  (mab) .

•      mo = mouse

•      u- human ,

•      xi=chimera ,

•      zu= humanised chimera

•       Immune  = lim

•      miscelleaneous tumor = tu

•      Receptor fusion protein (cept) alefacept

•      Receptor antagonist (ra) anakinara

What is Biopharmaceutical

– A drug created by means of  biotechnology, especially genetic engineering.

– A pharmaceutical inherently biological in nature and manufactured using biotechnology.

How biopharmaceuticals are made?

1.     Develop host cell

2.     Establish a cell bank

3.     Protein production

4.     Purification

5.     Analysis

6.     Formulation

7.     Storage and handling

Development of host cell

  • Identify the human DNA sequence for the desired protein
  • Isolate the DNA sequence
  • Select a vector to carry the gene
  • Insert the gene into the genome of a host (a suitable bacterial or eukaryotic cell)

 

The exact DNA sequence and the type of host cell used will significantly influence the characteristics of the product

Cell bank

  • A cell bank is then established, using an interative and elaborate cell screening and selection process, yielding a unique master cell bank.
  • No two master cell banks are exactly alike.

Making a generic drug is like making a bicycle whereas making a biologic is like making a Ferrari car.

What is biosimilar?

“A biosimilar is a biological product that is highly similar to an already approved biological product, not withstanding minor differences in clinically inactive components, and for which there are no clinically meaningful differences between the biosimilar and the approved biological product in terms of the safety, purity, and potency of the product”

  • Is a medicine which similar to biological /biopharmaceutical medicine that has already been authorized (the biological/ biopharmaceutical reference medicine).
  • The active substance of a biosimilar is similar to the one of biological/ biopharmaceutical reference medicine.

Used in the same dose to treat the same disease

What is the importance of biosimilar?

  • Biopharmaceuticals represent one of the fastest-growing segments of pharmaceutical industry.
  • By 2010 they are expected to represent 50% of the market.
  • Patent of original product expired.
  • Increase opportunity to healthcare services, decrease expenditures.

Biologics v/s Biosimilars

  • Biologics are highly targeted large molecule less side effects
  • Biosimilars follow on biologics2 or similar biological medicinal products
  • Generic version of biologics (Economical)
  • Similar in structure and function to reference products
  • It is similar but not identical

Storage and Handling

  • Biopharmaceuticals are very sensitive to temperature changes and/or shaking.
  • Strict storage and handling conditions are therefore  essential for maintaining product integrity and stability.
  • Poor adherence to (cold) storage requirements can affect clinical efficacy and safety.

Differences in manufacturing

  • The manufacturing process for a biopharmaceutical is far more complex than that for a low molecular weight drug.
  • For biopharmaceuticals, much more than for low molecular weight drugs, the quality of the end product (including therapeutic efficacy and safety) is depended on the manufacturing process.
  • 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
  • Drug is similar but not the copy of existing original drug.

Biologics are driving force in pharma industry

  • 30% new entities are biologics
  • Small molecule growth is declining v/s biologics is increasing
  • Chronic diseases best treated à biologics
  • Under patent
  • Premium pricing
  • High barrier to competition
  • Monoclonal antibodies is fastest growing market in the world.

Problems with biologics

  • Immunogenicity
  • Antibody production
  • Poor response
  • Larger dose needed
  • Costs
  • Infections Tuberculosis
  • Cancers lymphomas

In India following biosimilars are available by different Indian companies

1.Etanercept

2.Rituximab

3.Infliximab

4.Adalimumab

Biologics available in India for dermatologists

1. Omalizumab (Xolair)

2. Secukinumab (Scapho)

3.  Etanercept (Enbrel)

4.  Rituximab (Mabthera)

5 . Infliximab (Remicade)

Summary

  • Biosimilars are effective and are the future
  • Economical  (Biosimilars  costs 1/5th  less of the original )
  • Reducing duration of disease with a better control over it
  • Thus, improving patients Quality  Of  Life