Welcome to Pharma Utility, a magazine dedicated to news and services in the
Indian pharmaceutical industry.
Dean, Pharma Sciences, Chitkara University
BIOLOGICS /BIOLOGICALS The Other Side of Spectrum in the Age of CORONA
Biologics are made from a variety of natural sources—human, animal molecule drugs, some biologics are intended to treat diseases and medical conditions. Other biologics are used to prevent or diagnose disease. The biologics now in development make use of a range of new technologies to harness scientiﬁc progress, as follows:
● Monoclonal antibodies
● Vaccines, including therapeutic vaccines
● Blood and blood products for transfusion and/or manufacturing into other products
● Gene therapies
● Cell therapies
● Antisense Therapies
● Recombination Fusion Protein Therapy
● Stem Cell Therapies
● Tissue Engineering
Biosimilars,Biosuperiorsorthe original, innovative compound – are all complex treatments, they do not share the same regulatory pathway to approval orinvolve the same level of investment or risk.A ﬁrst-in-class product has greatest riskasitrequiresidentifyinganew target,andsubsequently developingatherapeutic compoundforthattargetand validating the target mechanism for disease intervention in human. First-in-classbiologicssuchas monoclonalantibodiesuse advanced technologies such as recombinantDNA,and mammalianexpression techniques, and are very costly. It requiresmanufacturingfacilities with greater complexity than what is involved with small molecule drugs. And a very high cost for innovation which can be upto $1.2 billion.Biologicalsoﬀeramore targetedapproachtocancer management.Theycanactby turning oﬀ pathogenic pathways, activate apoptosis signalling, or evendownregulatesignal pathways,thusoﬀeringvarious options.
BiosimilarsOntheoppositesideofthe spectrumareBiosimilars.They have the lowest risk to a pipeline portfolio, as they essentially copy anexistingbiologicmolecule. Theyaresometimescalleda ‘follow-onbiologic’,‘subsequent entrybiologic’or‘similar biotherapeuticproduct’,abiosimilar is intended to be as much like the originaltherapyaspossible.In recentyears,somesimple biosimilar drugs, such as insulin, erythropoietin and interferon have been successfully developed and launchedUnliketherelativelyquick development and approval process for generic pharmaceuticals, most follow-on/Genericbiologicsmust undergoclinicaltrialtestingto demonstrate comparability to the originaltherapy.
Thisincludesshowingthatthe proﬁleofthecopyexactly replicates, or is at least similar to, theinnovatorproduct’s characteristics,including pharmacokinetics,mechanismof actionandrouteofadministration. There is a risk that subtle changes may cause the generic molecule to performdiﬀerentlyparticularlyin case of complex biologics, such as monoclonal antibodies or Fc fusion proteins, Manypharmaceuticalcompanies areracingtobecomeearlyentrants inthebiosimilarmarketplace. Biosimilarsrepresentan opportunity for a manufacturer to enteranewcategory,andrealisean economic return with a relatively smallinvestment.Atthesametime, incorporatingbiosimilarsintoa pipeline also reduces the portfolio’s