The Biotechnology IndustryOrganization (BIO) is grateful for the opportunityto respond to theIndian Guidelines on Similar Biologics:Regulatory Requirements for Marketing Authorization, hereafterreferred to as"Guidelines".
About BIO andthe Biotechnology Industry
BIO is atradeassociation representingmorethan1,100 companies, academiccentersand research institutions involved in the researchanddevelopment of innovative biotechnologyproducts and services. Our members areprimarilysmall-and medium- sized enterprises working to develop and commercializecutting-edgeproducts in the areas of healthcare, agriculture, energy,and the environment. Sinceits inception roughly 30years ago, thebiotechnologyindustryhas spurred the creationofmorethan one milliondirect jobs, and millions of related jobsin countries throughout theworld.
Thebiotechnologyindustryhas developed hundreds of innovativeproductsthat are helpingto heal, feed,andfuel theworld. In the healthcaresectoralone, this industryhas developed andcommercialized morethan 300 biotechnologytherapies, cures, vaccines, and diagnostics that arehelpingmorethan 325 million peopleworldwide who are sufferingfrom cancer,HIV/AIDS, and numerous otherserious diseases andconditions.
Another 400biotechnologymedicines arein thepipeline. In theagricultural field,biotechnologyinnovations areincreasingfood supplies, conservingnatural resources of land waterand nutrients,increasingfarm income,and growingtheeconomyworldwide. Within thefield ofindustrial biotechnology,biotech companies areleading the wayin creatingboth conventional and next generationadvanced biofuels,which can be produced from forest residues, algae, municipal solid waste, orother renewable sources of biomass,withoutcompromisingthe environment. Renewable chemicalsand biobased product platforms arealso providingreal opportunities to creategreen jobs, reduce dependenceon foreign oil, increaseenergysecurity,andreducegreenhousegas emissions.
India's biotechnologysector is a burgeoningone,with morethan 325 companiesand some with revenues in thebillions of dollars. Accordingto theBioSpectrum-ABLE (Association ofBiotechnologyLed Enterprises)BiotechIndustrySurveyof2011, the industryhasgrown by21.5% in 2006-2011, surgingto $4 billion. Foradditional information aboutIndia'sbiotechnologysector, pleaseseethe full9thBioSpectrum publication.1
BIO'sOverallViews onIndia's Guidelines onSimilarBiologics
At the outset, BIOwantstocommend the government ofIndia's MinistryofHealth in its endeavor to provideguidancefor companies engaged in developingsimilar biologics. BIO urges that in approvingSBPs, regulatoryauthorities ensurethat publicsafetyis the top priority, andalso that incentives to innovate new products arenot undermined. As indicated bythe Guidelines,"biologics"arecomplexmedicines that aremanufactured usinglivingorganisms. Thesedrugs aredifferent and far morecomplexthan most small molecule chemical drugs, and includemanyof thelatest breakthrough medical therapies forserious and life-threateningillnesses, suchas cancer, multiplesclerosis, diabetes, and HIV/AIDS, as wellas manyserious rarediseases. Dueto their sizeand complexity, biologicsgenerallycannot be scientificallycharacterized to thesamedegreeas small molecule chemical drugs.
As theWorld Health Organization has recognizedin its guideline fortheevaluation of similar biotherapeuticproducts, similar biologic products, orSBPs, arenot– and cannot betreatedas--genericdrugs. Agenericdrugis aproduct that is shown to be thesameas an innovative drug, and is generallydesignated astherapeuticallyinterchangeable with the innovator drug. Unlikegenericdrugs, an SBPis a product that is similar to, but not the same as, the innovator drug. Therecognitionofthe scientificdifferences between drugsand biologics is critical in assessingthe types anddegrees of teststhat maybe necessaryto demonstratean SBP’s quality, safetyand efficacyprofiles. Because of the complexscienceinvolvedwith manufacturingbiosimilar medicines, manyadvanced regulatoryagencies2haveindicated that thegenericdrugapproval pathwayis not appropriateforcomplexbiologics. TheWorld Health Organization'sguidelines referenced above, mayserveas a startingpointforanyscientificallybased regulatory approval pathwayforbiologics.
Moreover,while it is important to ensurethat safe and effectiveSBPs reachthe hands of patients who need them,itis important also not tolose sight of the need fornew and innovative products as well. Accordingly, in developing guidelines fortheapproval and marketingof SBPs, thegovernment ofIndia should ensurethat incentives to research, develop and manufacturenew and innovative therapies and cures, as wellas new indications forsuchproducts, arepreserved. In particular, itis important that there be substantial non-patent data exclusivitygranted to the original innovatorduringwhich time SBPmanufacturerscould notrelyonanyhealth authority’s priorapproval of the innovator’s ReferenceBiologic Product (RBP).