HOME > BUSINESS > Mylan and Biocon submits breast cancer drug application to USFDA

Mylan and Biocon submits breast cancer drug application to USFDA

canMylan N.V. and Biocon Ltd. said they submitted Mylan’s biologics license application for a proposed biosimilar Trastuzumab, to the U.S. Food and Drug Administration.

Biosimilar trastuzumab is a proposed biosimilar to branded Trastuzumab, which is indicated to treat certain HER2-positive breast and gastric cancers.

HER2-positive breast cancer is a breast cancer that tests positive for a protein called human epidermal growth factor receptor 2 (HER2), which promotes the growth of cancer cells.

Mylan and Biocon said that this has the potential to be the first submission of a proposed biosimilar trastuzumab in the U.S.

Mylan President Rajiv Malik said, “The FDA submission for biosimilar trastuzumab marks Mylan’s first FDA biosimilar submission from our broad portfolio of biosimilar products in development and our product has the opportunity to be the first biosimilar trastuzumab approved in the U.S.”

“Our trastuzumab biosimilar is already being sold in 11 developing markets, including India, and we look forward to bringing the product to market in the U.S. and Europe upon approval.”

The submitted license application includes a package of analytical similarity, nonclinical and clinical data. The clinical data consists of two pharmacokinetic studies and the heritage confirmatory efficacy and safety trial.

The results of the heritage trial were presented at this year’s American Society of Clinical Oncology (ASCO) annual Meeting and the European Society for Medical Oncology (ESMO) Congress.

Dr Arun Chandavarkar, CEO & Joint MD, Biocon, said, “Cancer patients in India and emerging markets have benefited with our trastuzumab and this advancement in the U.S. will enable us to enhance access to this affordable therapy to larger patient pools.”

Mylan and Biocon are partners on a portfolio of biosimilar and insulin products. The proposed biosimilar trastuzumab is one of the six biologic products co-developed by Mylan and Biocon for the global marketplace.

Mylan has commercialization rights for the proposed biosimilar trastuzumab in the U.S., Canada, Japan, Australia, New Zealand and in the European Union and European Free Trade Association countries.

Biocon has co-commercialization rights with Mylan for the product in the rest of the world.

Mylan is a global pharmaceutical company which offers a more than 2,700 generic and branded pharmaceuticals, including antiretroviral therapies on which approximately 50% of people being treated for HIV/AIDS worldwide depend.

It has markets in more than 165 countries and territories with 40,000 employees.

Biocon Limited is India’s largest and fully-integrated biopharmaceutical company.

Some of its key brands are INSUGEN (rh-insulin), BASALOG (Glargine), CANMAbTM (Trastuzumab), BIOMAb-EGFRTM (Nimotuzumab) and ALZUMAbTM (Itolizumab), an anti-CD6 monoclonal antibody.

Follow ULTRA.news
Zydus Cadila gets USFDA nod to launch generic version of billion-dollar drug Cialis eventually The United States Food and Drug Administration has given Zydus Cadila approval to launch a generic version of the billion-dollar erectile dysfunction drug Cialis when patents expire.The patents are expected to expire in September next year.Cialis and Viagra are the most ...
Biocon launches colon cancer drug in India, priced Rs 24,000 Pharmaceutical company Biocon has launched KRABEVA, a biosimilar Bevacizumab for the treatment of patients a variety of cancers in India.The biosimilar -- or a drug that mimics a natural protein -- is useful in treating metastatic colorectal cancer and other types of lung, k...
Glenmark Pharma to launch birth control pill in USA Glenmark Pharmaceuticals said it got the approval of the United States Food & Drug Administration to launch a generic version of birth control pill Loestrin from Allergan Pharmaceuticals International.The drug had annual sales of approximately $116.8 million.The drug Nor...
Strides Shasun gets USFDA nod to launch nausea drug Strides Shasun Limited said it received approval from the United States Food & Drug Administration (USFDA) to launch a generic version of Diamox Tablets.The primary use of the Acetazolamide is to reduce nausea and dizziness associated with altitude sickness, but the drug is ...
After Lupin, Ajantha Pharma too launches generic ADHD drug in US A month after Lupin got it, Ajanta Pharma too said it got the approval to launch a generic version of Concordia Pharmaceuticals Inc.’s ADHD drug Kapvay.Lupin had got the nod in October, and said the drug had sales of around $66 mln in the US.Ajantha Pharma also said it ha...
Cipla gets US approval for cancer drug, Glenmark for oral contraceptive Two Indian pharmaceutical companies, Cipla and Glenmark, said they received approval from the US Food and Drug Administration for new drugs.While Cipla got the nod for a drug used to treat a type of blood cancer, Glenmark was approved to sell an oral contraceptive.Cipla...
Zydus gets nod for anti-inflammation drug in the US Pharma major Zydus Cadila said it received final approval from the USFDA to market an anti-inflammatory injection Ethacrynate Sodium in the US.The drug is used to decrease the Swelling (edema) caused by various disease conditions such as liver disease, kidney disease, conges...
Lupin gets USFDA warning on Goa, Indore plans, to affect new approvals Pharma major Lupin said it a warning letter from the US Food and Drug Administration for its formulations manufacturing facilities in Goa and Indore on Monday."We are deeply disappointed to hove received this outcome. While there will be no disruption of existing product sup...
Biocon, Mylan apply again for EU approval for cancer drugs trastuzumab, pegfilgrastim Biocon said its partner Mylan has resubmitted the marketing application for two substances used to treat cancer -- trastuzumab and pegfilgrastim -- before European authorities after making changes to their production facilities.The drug applications before the European Medic...
Lupin gets USFDA approval for generic ADHD drug Pharma Major Lupin said it received final approval from the United States Food and Drug Administration (FDA) to market a generic version of Concordia Pharmaceuticals Inc.’s ADHD drug Kapvay.It had annual sales of approximately USD 66 million in the US.Clonidine Hydrochlo...
USFDA returns Mylan-Biocon’s drug application for more data The U.S. Food and Drug Administration has sought more data before approving a chemotherapy compound submitted by Mylan and jointly developed by Biocon.The agency issued a 'complete response letter'. Such letters are issued when an FDA review an FDA review finds that an appli...
Lupin gets FDA nod to launch heart drug in the US Pharma manufacturer Lupin said it received approval to launch the generic version of US World Meds' Corgard heart drug.Nadolol Tablets USP, 20 mg, 40 mg, and 80 mg Tablets had annual sales of approximately USD 109.8 million in the US, the Indian drugmaker said.Lupin's N...
Zydus Cadila gets USFDA nod for overactive bladder drug Zydus Cadila said it received the final approval to launch overactive bladder drug Fesoterodine Fumarate in the US.The sales of Fesoterodine Fumarate Extended-Release Tablets are estimated at $195.5 million.It will be manufactured at the group’s formulations manufacturin...
NATCO Pharma to sell multiple sclerosis drug in USA via Mylan NATCO Pharma Limited said it the US Food and Drug Administration approved the generic drug application filed by its marketing partner Mylan for injections used in the treatment of multiple sclerosis, a chronic inflammatory disease of the central nervous system.The drug, Glat...
Glenmark to launch Desonide topical ointment in US Glenmark Pharmaceuticals Inc said it has got the go-ahead to launch the generic version of Perrigo's anti-inflammation ointment Desonide Ointment in the US.Desonide Ointment, 0.05% had annual sales of approximately $23.4 million for the 12 month period ending July 2017, acco...
Biocon passes US-FDA inspection at Vishakapatanam plant Biocon said the plant inspection conducted by the US Food and Drug Administration at its Vishakapatanam plant passed without incident."US FDA inspected our Active Pharmaceutical Ingredients (API) manufacturing facility in Wishakhapatnam, Andhra Pradesh from September 11 to 1...
Panacea Biotec to supply heart drug to Apotex for US market Pharma company Panacea Biotec said it has signed an agreement to supply a generic version of Eli Lilly's Effient heart drug to Apotex, the largest Canadian-owned pharmaceutical company.The drug will be sold by Apotex in the US market."Under the terms of the agreement, Ap...
Zydus Cadila to launch immuno-suppressant in the US Pharma giant Zydus Cadila said it received final approval from the USFDA to market immunonsuppressant Mycophenolate Mofetil injection.The drug is indicated for use in combination with other drugs i.e., cyclosporine and corticosteroids for the prophylaxis of organ rejection ...
Jubilant Life Sciences gets US-FDA approval for pain drug Pharma company Jubilant Life Sciences Ltd said it received final approval to sell pain drug Indomethacin in the US.The drug, which is also sold as Indocin by Iroko in the US, is a nonsteroidal anti-inflammatory drug used for the treatment of moderate to severe inflammation a...
Glenmark Pharma gets USFDA approval for generic version of Mylan’s anti-inflammation ointment Glenmark Pharmaceuticals said it has got the US FDA approval to sell the generic version of corticosteroid ointment Kenalog from Mylan Pharmaceuticals.The primary ingredient is triamcinolone, a corticosteroid that reduces the actions of chemicals in the body that cause inflam...