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Biosimilars

Biosimilars

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  1. BIOSIMILARS Prepared By Ms. Prexita Patel Dept. of Pharmacology Anand Pharmacy College, Anand

  2. Biosimilar Biosimilar are highly similar to the reference product in terms of safety, purity and potency, but may have minor differences in clinically inactive components. In approving biosimilar, the FDA may require that manufacturers conduct a clinical study (or studies) sufficient to establish safety, purity or potency in one or more uses for which the reference product is licensed and the biosimilar seeks licensure. A generic drug is chemically identical to its brand-name counterpart—an exact copy. The generic drug and brand-name drug have the same active ingredient, dosage form, safety profile, strength, route of administration, performance characteristics, and intended use. Accordingly, the brand-name drug and generic drug are considered to be bioequivalent.

  3. A biosimilar is not an exact duplicate of another biologic. There is a degree of natural variability in all biological products; it is not possible to generate a precise copy of a product that comes from living cells. All biologics—including reference products—show some batch-to-batch variation. A biosimilar may have a different structure than the reference product, but the active substances are essentially the same in molecular and biological terms. This means that there are no clinically meaningful differences between the biosimilar and reference product in terms of safety or effectiveness. Only minor differences in clinically inactive components are allowable. The first biosimilar product in the United States, Zarxio, was approved in March 2015 and marketed in September 2015. Zarxio (filgrastim-sndz) is a biosimilar of Neupogen (filgrastim), a medication that helps to reduce the risk of infection in patients with certain types of cancer who are receiving chemotherapy that decreases the number of white blood cells.

  4. EXAMPLES OF BIOSIMILAR Aranesp (darbepoetinalfa) Erythropoiesis-stimulating agent (ESA) for anemia due to chronic kidney disease (CKD) in patients on dialysis and patients not on dialysis. Enbrel (etanercept) Nature and indication:Tumor necrosis factor (TNF) blocker for rheumatoid arthritis, polyarticular Juvenile Idiopathic Arthritis (JIA) in patients aged two years or older; psoriatic arthritis; ankylosing spondylitis; and plaque psoriasis Epogen® / Procrit® / Eprex / Erypo (epoetinalfa) Erythropoiesis-stimulating agent for anemia due to chronic kidney disease in patients on dialysis and not on dialysis. Also, for reduction of allogeneic RBC transfusions in patients undergoing elective, noncardiac, nonvascular surgery.

  5. Genotropin (Somatropin or somatotropin) Peptide human growth hormone for children with growth failure due to growth hormone deficiency (GHD), Prader-Willi syndrome, small for gestational age, Turner syndrome, and idiopathic short stature; and for adults with either adult onset or childhood onset GHD. Herceptin (trastuzumab) Monoclonal antibody; Human epidural receptor 2 (neu) receptor antagonist for aggressive HER positive metastatic and adjuvant breast cancer, for aggressive HER positive metastatic stomach or gastroesophageal junction cancer. Humira (Adalimumab) Anti-TNF-α monoclonal antibody for moderate to severe rheumatoid arthritis, moderate to severe chronic plaque psoriasis, moderate to severe Crohn’s disease; moderate to severe ulcerative colitis, ankylosing spondylitis, psoriatic arthritis, moderate to severe polyarticular juvenile idiopathic arthritis.

  6. Neulasta (pegfilgrastim) Leukocyte growth factor indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with nonmyeloidmalignancies. Neupogen (filgrastim) Granulocyte colony-stimulating factor (G-CSF) for neutropenia caused by the drugs used to treat cancer. Remicade (infliximab) Tumor necrosis factor (TNF) blocker for moderately to severely active rheumatoid arthritis in adults, in combination with methotrexate; Crohn’s disease in children six years and older. Rituxan / MabThera (rituximab) Chimeric mouse-human monoclonal antibody, for non-Hodgkin’s lymphoma, chronic lymphocytic leukaemia, and rheumatoid arthritis.