Biosimilar Injections

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Reliferon Injections
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Reliferon Injections

ReliFeron® belongs to the class of interferons (IFNs) which are natural proteins produced by the cells of the immune system in response to foreign agents such as viruses, bacteria, parasites and tumor cells. Interferons are produced in body primarily from leukocyte, fibroblast and immune cell and the important ones are Interferons assist the immune response by activating natural killer cells and macrophages, promoting antigen presentation to lymphocytes and thus inducing the resistance of host cells against foreign agents. Interferons also have direct anti-viral effects. Recombinant IFN-a is now approved worldwide in over 40 countries for the treatment of more than 14 malignancies and viral diseases, including adjuvant therapy in metastatic melanoma, condyloma acuminata, Kaposi's sarcoma and most importantly hepatitis B and C. Interferon-a has been shown to be effective in suppressing viral replication and in inducing remission of liver disease caused by chronic hepatitis B and hepatitis C virus infection. ReliFeron®is a purified sterile human recombinant interferon product classified as an alpha interferon. It has 165 amino acids, with a molecular weight of 19 kDa. ReliFeron® is obtained by recombinant technology using Escherichia coli with an interferon alpha 2b gene from human leukocytes. It is used in the form of parenteral injection. Each vial of ReliFeron®contains 3 or 5 million IU recombinant human interferon alpha 2b in 0.5 mL of aqueous buffer.

Relipointin Injections
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Relipointin Injections

Erythropoietin (EPO) belongs to the class of Erythropoiesis Stimulating Agents, i.e it work as a growth hormone and stimulates production of red blood cells from the hematopoietic stem cells in the bone marrow. It is solely produced by the kidney cells, and thus, any functional damage to the kidneys can result in EPO deficiency and reduction in production of RBC pool that eventually leads to anemia. ReliPoietin® is erythropoietin alpha, conventionally used to reverse anemic condition that is arising because of body's inability to produce required amount of erythropoietin, and thus, reduced pool of red blood cells. It is used as a support therapy in the treatment of Acute, chronic and end-stage renal failure; in cancer-induced and chemotherapy-related anemia; in patients undergoing major surgeries; and in AIDS patients on zidovudine treatment. The aim of therapy is to reduce the number of dialysis required by the renal failure patients, better tolerance of chemotherapy and reduced number of blood transfusions in case of cancer patients; and overall improved quality of life in these patients. ReliPoietin®, is a glycoprotein containing 165 amino acids. The molecular weight is 30 kD, with 40% glycosylation. The upstream processing including the cell lines (Chinese Hamster Ovary) used and the downstream processing yields erythropoietin that is exactly similar to the innovator's product. Even the isoform distribution, which is one of the determinants of efficacy, is same as that of the innovator's product and the biological reference protein. ReliPoietin® is available as pre-filled syringes in the strengths of 2000, 3000, 4000, 6000, 10,000 and 40,000 IU

Religrast Injections
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Religrast Injections

ReliGrast® is human recombinant Granulocyte Colony Stimulating Factor (G-CSF), which is a specific growth factor known to stimulate production of neutrophils, a type of white blood cells in the body that are essential for fighting infections. It is active during the normal course of hematopoiesis and the hematopoietic stem cells get differentiated into white blood cells in the presence of G-CSF. G-CSF is a protein having 175 amino acids, and has no glycosylation. E.coli is used for commercial manufacturing of recombinant G-CSF as a biosimilar. ReliGrast® can be therapeutically used for reversing neutropenic conditions due to various reasons. It can be used in chemotherapy induced neutropenia, AIDS-associated neutropenia, congenital, cyclic idiopathic neutropenia. In the clinical trials conducted, ReliGrast® has demonstrated efficacy in reducing the duration of Neutropenia (compared to 9 days) and recovery after ANC Nadir. The reduction in the incidence of Febrile Neutropenia, Grade 4 Neutropenia and Infection is also significant. ReliGrast® is available in the strength of 300 mcg/0.5 ml, as a pre-filled syringe.

Fostirel Injections
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Fostirel Injections

FostiRel™ is recombinant follitropin beta stimulating hormone(r-FSH). FSH is a fertility hormone that is responsible for folliculogenesis and ovulation in females . It also indicated for spermatogenesis in males. Amongst females with infertility, ovulatory problems like anovulation are responsible for around 25% of cases, while in case of males, azoospermia or oligzoospermia are most prominent contributing reasons. Recombinant FSH, since it is a pure protein product, containing only FSH and no contaminants, subcutaneous administration is advocated. In this case, the pharmacokinetics does not seem to be affected. Subcutaneous administration, in fact, improves the patient compliance. FostiRel™ is available as multi dose vials in strengths of 300 IU, 900 IU and 1200 IU. Multiple tests prove the product to be exactly similar to the innovator, in terms of product identity and purity.

Relibeta Recombinant interferons Beta 1A
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Relibeta Recombinant interferons Beta 1A

Interferons are a family of naturally occurring proteins and glycoproteins that are produced by eukaryotic cells in response to viral infection and other biological inducers. Interferon beta, a member of interferon family, is produced by various cell types including fibroblasts and macrophages. Recombinant interferon beta-1a is a glycosylated protein with a single N-linked glycosylation site, similar to the natural interferon beta-1a. Interferon beta exerts its biological effects by binding to specific receptors on the surface of human cells. This binding initiates a complex cascade of intracellular events that leads to the expression of numerous interferon-induced gene products and markers. The actions of interferon beta have the net effect of reducing the immune response that is directed against central nervous system myelin in people with MS. ReliBeta™ (recombinant Interferon beta-1a) is a 166 amino acid glycoprotein with a molecular weight of approximately 22 kD. It is produced by recombinant DNA technology using genetically engineered Chinese Hamster Ovary cells into which the human interferon beta gene has been introduced. The amino acid sequence of ReliBeta™ is identical to that of natural human interferon beta. ReliBeta™ is indicated for the treatment of patients with relapsing forms of multiple sclerosis to slow the accumulation of physical disability and decrease the frequency of clinical exacerbations. Patients with multiple sclerosis in whom efficacy has been demonstrated include patients who have experienced a first clinical episode and have MRI features consistent with multiple sclerosis. ReliBeta™ is a sterile, preservative-free, clear colourless liquid for intramuscular injection. ReliBeta™ is available as a ready for use pre-filled glass syringe with 0.5 ml fill volume. Each 0.5 ml in a pre-filled glass syringe contains 30 µg of interferon-beta-1a in sodium acetate aqueous buffer containing L-arginine hydrochloride and polysorbate 20.

Reliseal Fibrin Sealant
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Reliseal Fibrin Sealant

ReliSeal® is biological glue and haemostatic agent, which can be used in a variety of surgical procedures to arrest bleeding, seal tissues and as an adjunct to wound healing. A quick acting surgical fibrin sealant derived from human blood plasma, with haemostatic sealing and adhesive properties, ReliSeal® mimics the final stage of the natural clotting mechanism. The kit is available in 0.5 ml and 1 ml pack size.

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Mirel Injections

MIRel™ (Reteplase) is a single chain deletion mutant of alteplase that is expressed in Escherichia coli and, therefore, is expressed as an unglycosylated protein (355 amino acids) with a total molecular weight of 39 kDa. The molecule consists of cringle 2 and the protease domain of the alteplase molecule. Because of the deletion of the fibronectin finger region, the binding of reteplase to fibrin is significantly reduced in comparison with that of alteplase. Although kringle 2 (known to stimulate protease in the presence of fibrin) is part of the reteplase molecule, reteplase is stimulated in the presence of fibrin to a lower extent than alteplase, suggesting that the fibronectin finger is involved in the stimulation of the protease as well. Reteplase, in comparison with alteplase, is characterised by reduced fibrin selectivity. In the abscence of fibrin, reteplase and alteplase do not differ with respect to their activity as plasminogen activators, nor do they differ with respect to their inhibition by the plasminogen activator inhibitor type 1 (PAI-1). The elimination of reteplase from the circulating plasma predominantly occurs in the liver. Because of the deletion of the fibronectin finger region, the epidermal growth factor domain and kringle 1, as well as the carbohydrate side chains, the hepatic elimination of the molecule is reduced. Consequently, plasma half life is increased to 14-18 minutes (versus 3-4 minutes with alteplase). This allows reteplase to be administered as boli (versus as an initial bolus followed by an infusion, as with alteplase). The best results have been obtained with a double bolus of 10 U each 30 minutes apart in the case of an acute myocardial infarction. Reteplase was superior to alteplase (administered over three hours) with respect to patency of the infarct related coronary artery. With reteplase patency was reached earlier and more frequently than with alteplase. Each kit of MIRel contains two vials of 10 units of Reteplase each, sterile water for injection, two syringes and four needles

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