Con­scio Group and Paras Bio­phar­ma­ceu­ti­cals part­ner to advance romi­plostim biosim­i­lar toward Euro­pean and US reg­is­tra­tion

Con­scio Group, a Euro­pean research ser­vice provider to the Phar­ma­ceu­ti­cal Indus­try, and Paras Bio­phar­ma­ceu­ti­cals Fin­land Oy, a Finnish bio­log­ics devel­op­er, today announced a part­ner­ship to advance PBR-401, a biosim­i­lar can­di­date of romi­plostim, toward mar­ket­ing autho­ri­sa­tion in the Euro­pean Union and the Unit­ed States.

Under the agree­ment, Con­scio Group will car­ry out the clin­i­cal and ana­lyt­i­cal work pro­gramme required to take PBR-401 through to reg­is­tra­tion with the Euro­pean Med­i­cines Agency (EMA), includ­ing phar­ma­co­ki­net­ic study exe­cu­tion and bio­an­a­lyt­i­cal and ana­lyt­i­cal test­ing. Reg­is­tra­tion with the EMA is planned as the first step, to be fol­lowed by an appli­ca­tion for approval by the U.S. Food and Drug Admin­is­tra­tion (FDA), with the Euro­pean data pack­age sup­port­ing sub­se­quent entry into the Unit­ed States. Paras Bio­phar­ma­ceu­ti­cals, which devel­oped PBR-401 and owns the asset, con­tributes the prod­uct togeth­er with its pro­pri­etary micro­bial pro­duc­tion tech­nol­o­gy. The pro­gramme will draw on Con­scio Group’s in-house clin­i­cal units and EMA- and FDA-inspect­ed lab­o­ra­to­ries in the Czech Repub­lic.

Romi­plostim is a throm­bopoi­etin recep­tor ago­nist used in the treat­ment of chron­ic immune throm­bo­cy­tope­nia (ITP), a seri­ous blood dis­or­der in which per­sis­tent­ly low platelet counts can lead to bruis­ing and bleed­ing. As a biosim­i­lar, PBR-401 is intend­ed to broad­en patient access to this ther­a­py and to help health­care sys­tems man­age the cost of bio­log­ic treat­ment.
The part­ner­ship was signed at Con­scio Group’s Bio­log­ics and Advanced Mol­e­cules Day on May 28th in Prague, an event con­ven­ing sci­en­tists, reg­u­la­tors and indus­try part­ners around cur­rent devel­op­ments in bio­log­ics and advanced ther­a­peu­tics. H.E. Mr. Pasi Tuomi­nen, Ambas­sador of Fin­land to the Czech Repub­lic, attend­ed the sign­ing, reflect­ing the partnership’s sig­nif­i­cance for sci­en­tif­ic and com­mer­cial coop­er­a­tion between Fin­land and the Czech Repub­lic.

“We are priv­i­leged to sup­port Paras in advanc­ing PBR-401, a pro­gramme built on years of ded­i­cat­ed sci­ence,” said Stephan Holl, CEO of Con­scio Group. “Our part is to bring rig­or­ous clin­i­cal and ana­lyt­i­cal exe­cu­tion to that effort, and we are con­fi­dent in the route ahead toward bring­ing a high-qual­i­ty romi­plostim biosim­i­lar to patients. To begin this work here, among our sci­en­tif­ic com­mu­ni­ty, makes the occa­sion all the more mean­ing­ful.”

“Paras has invest­ed years of sci­ence into PBR-401, and select­ing the right part­ner to take it through Euro­pean reg­is­tra­tion was a deci­sion we did not make light­ly,” said Dr. Ashesh Kumar, Founder and CEO, Paras Bio­phar­ma­ceu­ti­cals Fin­land Oy. “In Con­scio Group we have a part­ner with the clin­i­cal and ana­lyt­i­cal exper­tise this pro­gramme needs, and a shared com­mit­ment to qual­i­ty. We are pleased to begin this work and con­fi­dent in the path toward mar­ket approval.”

About Con­scio Group
Con­scio Group is a Euro­pean GMP/GLP/GCP/IEC-cer­ti­fied, EMA- and FDA-inspect­ed sci­en­tif­ic ser­vice provider. Head­quar­tered in Munich, the group brings togeth­er estab­lished lab­o­ra­to­ries and clin­i­cal units
across Ger­many, Aus­tria, Czechia and Slo­va­kia, offer­ing inno­va­tion and for­mu­la­tion devel­op­ment, clin­i­cal tri­als and bio­analy­sis, qual­i­ty con­trol, and GMP man­u­fac­tur­ing solu­tions for small and large mol­e­cules, gener­ics and biosim­i­lars.

About Paras Bio­phar­ma­ceu­ti­cals Fin­land Oy
Paras Bio­phar­ma­ceu­ti­cals Fin­land Oy is a bio­log­ics devel­op­er based in Oulu, Fin­land. The com­pa­ny devel­ops and licens­es biosim­i­lar and recom­bi­nant pro­tein prod­ucts, sup­port­ed by pro­pri­etary micro­bial pro­duc­tion tech­nolo­gies and an in-house man­u­fac­tur­ing facil­i­ty in Fin­land. Its devel­op­ment port­fo­lio includes the romi­plostim biosim­i­lar can­di­date PBR-401.

Source (text and image): Paras Bio­phar­ma­ceu­ti­cals