The therapy — dimethyl fumarate delayed-release capsules — is indicated for use in people with clinically isolated syndrome (CIS), relapsing-remitting MS (RRMS), and active secondary progressive MS (SPMS). Similar to Tecfidera, by Biogen, Lupin’s generic equivalent will be available in two doses, 120 mg and 240 mg.
Lupin anticipates launching the treatment shortly in the U.S. market.
Tecfidera is an oral FDA-approved therapy for the treatment of adults with relapsing MS. It works by decreasing inflammation and preventing nerve damage that may cause the disease’s symptoms. Lupin’s newly approved generic equivalent is indicated for the same forms of the disease as the original therapy.
Headquartered in Mumbai, India, Lupin develops and commercializes branded and generic formulations in several markets, including the U.S. According to its website, Lupin has received more than 250 FDA approvals and markets a total of 180 generic products. Lupin is the third-largest pharmaceutical company in the U.S. based on the number of prescriptions, the company said.
The approval of generic products by the FDA follows a rigorous review process to ensure that the generic alternative contains the same active ingredient, strength, dosage form, and route of administration as the original brand-name product — in this case, Tecfidera.
Further, “all generic drugs approved by FDA have the same high quality, strength, purity, and stability as brand-name drugs,” the agency states.
While generics are equally safe and effective as the brand-name product, they usually are a lower-cost alternative.
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