List of Authorized Biosimilars (as of 1 January 2019)

The first regulation on pharmaceuticals was in 1989 this include registration of vaccines. In 2001 the specific regulation of vaccines and biological products was signed into law, this provides guidance on how to register vaccines and biologicals in the country. Through the years we have seen a number of developments and innovations in the field of biologicals. However, their cost has often been high which limits the access of patients in developing countries. The expiration of patents of innovative biological products has ushered in a new phase in biological product development in which a product may be considered “similar” to the innovator. This resulted in the issuance of guidelines on “biosimilar” or “similar biotherapeutic” products in 2014.

Since then the FDA has licensed four (4) biosimilar products namely:

  • Insulin Glargine (Basaglar) 100 IU / mL
  • Insulin Glargine (Basaglar Kwikpen) 100 IU / mL
  • Filgrastim (Zarzio) 30 MU / 0.5 mL
  • Rituximab (Truxima) 500mg / 50 mL
No. COMPANY REGISTRATION NUMBER ACTIVE SUBSTANCE BRAND NAME PHARMACOLOGIC CATEGORY STRENGTH FORM MANUFACTURER PACKAGING
1 ELI LILLY (PHILIPPINES), INC. BRP-058 Insulin Glargine Basaglar Antidiabetic 100 Units/mL Solution for Injection (SC) Lilly, France 3 mL solution in a cartridge (type I colourless glass) with a plunger (chlorobutyl rubber) and a disc seal (laminate of polyisoprene and bromobutyl rubber) with aluminum seal. Box of 1’s and 5’s.
2 ELI LILLY (PHILIPPINES), INC. BRP-059 Insulin Glargine Basaglar Kwikpen Antidiabetic 100 Units/ mL Solution for Injection (SC) Lilly, France 3 mL solution in a cartridge (type I colourless glass) with a plunger (chlorobutyl rubber) and a disc seal (laminate of polyisoprene and bromobutyl rubber) with aluminum seal. Box of 1’s and 5’s.
3 Sandoz Philippines Corporation BR-1198 Filgrastim Zarzio Immunostimulant, colony stimulating factor 30 MU/0.5mL Solution for Injection / Infusion IDT Biologika GmbH, Germany Pre-filled syringe (type I glass) with injection needle (stainless steel), with a needle safety guard, containing 0.5mL solution (box of 5’s)
4 Celltrion Healthcare Philippines Inc. BR-083 Rituximab Truxima Antineoplastic 500 mg/50 mL Concentrate for Solution  for Infusion Celltrion Incorporated (Plant 2), Korea 50 mL Type I borosilicate glass vial with rubber stopper and flip-off seal (Box of 1’s)
PHP Code Snippets Powered By : XYZScripts.com