UP­COM­ING BIOSIM­I­LARS OP­POR­TU­NI­TIES

BioSpectrum (Asia) - - Bio Edit - Milind Kokje Chief Edi­tor milind.kokje@mmac­tiv.com

Is­sue of drug pric­ing seems no more re­stricted to only poor or de­vel­op­ing coun­tries. Even in sup­pos­edly rich and de­vel­oped coun­ties like US, it ap­pears to be as­sum­ing a lot of im­por­tance. En­sur­ing the ac­ces­si­bil­ity of medicines can be a cost-ef­fec­tive way of treat­ing sick­ness, as medicine is the most es­sen­tial com­po­nent of health care. But one of the im­por­tant com­po­nents of ac­ces­si­bil­ity is af­ford­abil­ity or price, which needs to be taken care of by the pol­icy mak­ers since af­ford­abil­ity and ac­ces­si­bil­ity are di­rectly pro­por­tional.

It is dis­turb­ing to learn that ac­cord­ing to ‘The Com­mon­wealth Fund’ study in 2014, 35 mil­lion Amer­i­cans could not af­ford pre­scrip­tion medicines. Amer­i­can Heart As­so­ci­a­tion es­ti­mates that fail­ure to take a pre­scribed medicines or re­duc­ing its dosage costs $ 300 bil­lion ex­tra in med­i­cal ex­penses and con­trib­utes 125,000 deaths a year. The rea­son be­ing that medicines sold in Canada are 55% less costly than US, points out Web. Reuter’s anal­y­sis says prices of top 20 sell­ing medicines are on an av­er­age triple than in Bri­tain. As a re­sult, 5 mil­lion Amer­i­cans bought their medicines from other coun­tries in 2013 to save money. Kaiser Fam­ily Foun­da­tion poll of Novem­ber 2016 found out that 19 mil­lion Amer­i­cans im­port medicines from Canada or other coun­tries.

That shows Amer­i­cans are feel­ing the pinch. In­dia, Europe and many other coun­tries are ei­ther pur­su­ing or try­ing to pur­sue the poli­cies to con­trol drug prices. US feels like fol­low­ing them if one reads the re­cent speech of Scott Got­tlieb, USFDA Head.

He an­nounced in Healthy Re­turns con­fer­ence that USFDA is work­ing on over a dozen poli­cies to pro­mote use of cheaper ver­sions of costly biotech medicines. The new poli­cies will be in di­rec­tion to cre­ate more av­enues for biosim­i­lar com­pe­ti­tion. USFDA has given pri­or­ity to ap­prov­ing generic drugs by pass­ing over 1,000 generic drugs in a year. It has ap­proved nine biosim­i­lar ther­a­pies. But only three of them have reached the mar­ket and six oth­ers have been caught into le­gal is­sues as they have been chal­lenged by drug­mak­ers to pro­tect their own medicines.

Be­sides, The Al­liance for Health Pol­icy in its brief­ing ses­sion in July 2017 on drug af­ford­abil­ity and in­no­va­tion had con­sid­ered im­prov­ing ac­cess to gener­ics and biosim­i­lars as one of the ini­tia­tives for the pur­pose. One hin­drance in the process is per­mis­sion given to drug­mak­ers to pay generic man­u­fac­turer to de­lay in­tro­duc­ing generic called ‘pay for de­lay’.

In spite of such ob­sta­cles, will the bio­pharma sec­tor in Asia be able to take ad­van­tage of the USFDA an­nounce­ment of cre­at­ing more av­enues for biosim­i­lar com­pe­ti­tion is the key is­sue. It had hap­pened in case of gener­ics. The global gener­ics mar­ket had grown to ac­count for 38% of global pharma spend­ing when US adopted reg­u­la­tion favour­ing gener­ics in 1984, a LEK con­sult­ing re­port said. It added that Asia has led in gener­ics adop­tion with ap­prox­i­mately 40% of global gener­ics spend­ing com­ing from this re­gion. Be­ing a gener­ics driven area, the APAC re­gion is ex­pected to pro­vide good op­por­tu­nity for biosim­i­lars. As claimed by the APAC bioim­i­lars mar­ket fore­cast re­port, many Asians com­pa­nies have biosim­i­lars mol­e­cules un­der de­vel­op­ment. Over 300 biosim­i­lars are un­der de­vel­op­ment in the Asia re­gion. Within Asia, In­dia ap­pears to be in a good po­si­tion to take ad­van­tage of the sit­u­a­tion since it has over 50 biosim­i­lar prod­ucts as against 16 in Europe and only two in US. In­dian com­pa­nies are re­port­edly mak­ing sig­nif­i­cant in­vest­ments in biosim­i­lars de­vel­op­ment.

Asian com­pa­nies will have to adopt var­i­ous steps to en­ter into US biosim­i­lar mar­ket at a large scale. Un­der­stand­ing the reg­u­la­tory pro­cesses and main­tain­ing qual­ity are two key steps. With all such is­sues and ac­tions, will Asian pharma com­pa­nies be able to fol­low the gener­ics pat­tern is to be seen. Ex­perts are of the opin­ion that they will. If they do, then it will open up huge op­por­tu­ni­ties for Asian com­pa­nies in biosim­i­lars.

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