» Biosimilar Drug Products
Biosimilar Drug Products
Biosimilar Drug Products are the new biological
innovations that are developed similar to existing products but are
fundamentally different from standard chemical products in terms of
complexity and have identical structure to that of reference
product, thereby needing evidence of safety as well as efficacy before
approval. Here, all biosimilar products work as prescription only
medicines (POM) where as a practice it is good to mention brand name.
The range offered under this category includes Filgrastim Injection,
Pegfilgrastim Injection, Erythropoietin
Injection, Interleukin 2 Injection and Darbepoetin Injection.
Filgrastim Injection is available in vial form of
30mcg, 48mcg and finds usage in decreasing chance of infection in
people having certain types of cancer and are getting chemotherapy
medication which may decrease neutrophils (type of blood cell
required for fighting infection), in people undergoing bone marrow
transplants as well as in people having severe chronic neutropenia
where there is low number of neutrophils in blood. Being from the
class of medication called colony-stimulating factor, it works by
helping body make more neutrophils, it also finds usage in preparing
blood for leukapheresis which is a treatment where certain blood
cells are removed from body and returned to body following
Pegfilgrastim Injection finds use in reducing
chances of infection in people having certain types of cancer and
are receiving medication for chemotherapy for decreasing number of
neutrophils. From the class of medication called colony stimulating
factors, it assists the body in making more neutrophils and comes in
form of a solution (liquid) that can be injected subcutaneously and
is given as single dose for each chemotherapy session undertaken.
Erythropoietin Injection works as a glycoprotein
that stimulate RBC production which is produced in kidney area for
stimulating division as well as differentiation of committed
erythroid progenitors in bone marrow. The medication is formulated
in form of sterile, colorless liquid in isotonic sodium
chloride/sodium citrate buffered solution/as sodium chloride/sodium
phosphate buffered solution for administering through intravenous
(IV) or subcutaneous (SC) process.
Interleukin 2 Injection
Interleukin 2 Injection helps in boosting bodys
natural immune defense system and is of the family of BRMs that
include cytokines. The medication is used either
alone or in combination for the treatment of kidney cancer. Further,
functioning as biologic response modifier (BRM), the medication is
also available for treatment of advanced kidney cancer by
stimulating growth of two types of WBCs - T cells and NK
cells. Here, T cells help body fight against cancer as they have
ability to recognize cancer cells and in setting off alarm to body.
Further, NK cells respond to alarm and become transformed into
lymphokine-activated killer (LAK) cells that are capable of
destroying cancer cells.
Darbepoetin Injection is used for treating
anemia, a case when RBC count is lower than normal in people facing
conditions of chronic kidney failure. The Darbepoetin alfa injection
also finds usage in treating anemia that is resultant of
chemotherapy in people having certain types of cancer. However, the
injection cannot be used as a supplement of red blood cell
transfusion for treating severe anemia. From the class of medication
called erythropoiesis-stimulating agents (ESAs), the medication
works by causing bone marrow in making more red blood cells.
Lenalidomide (trade name Revlimid) is a derivative of thalidomide introduced in 2004.
It was initially intended as a treatment for multiple myeloma, for which thalidomide is an accepted therapeutic treatment. Lenalidomide has also shown efficacy in the class of hematological disorders known as myelodysplastic syndromes (MDS). Along with several other drugs developed in recent years, lenalidomide has significantly improved overall survival in myeloma (which formerly carried a poor prognosis), although toxicity remains an issue for users
Multiple myeloma is a cancer of the blood, characterized by accumulation of a plasma cell clone in the bone marrow. Lenalidomide is one of the novel drug agents used to treat multiple myeloma. It is a more potent molecular analog of thalidomide, which inhibits tumor angiogenesis, tumor secreted cytokines and tumor proliferation through the induction of apoptosis.
Compared to placebo, lenalidomide is effective at inducing a complete or "very good partial" response as well as improving progression-free survival. Adverse events more common in people receiving lenalidomide for myeloma were neutropenia (a decrease in the white blood cell count), deep vein thrombosis, infections, and an increased risk of other hematological malignancies