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) |