Global pharma Cipla has announced that it has received final approval for its generic therapeutic equivalent version of Biogen (BIIB) IDEC Inc.’s Tecfidera.
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The product is available for shipping immediately, says Cipla, which will also be providing Co-Pay Assistance.
Cipla received Abbreviated New Drug Application (ANDA) for Dimethyl Fumarate DR Capsules 120mg, 240mg and 120mg/240mg Starter Pak from the United States Food and Drug Administration (US FDA).
The treatment is approved for relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.
According to IQVIA, Tecfidera had US sales of approximately $3.8 Billion for the 12-month period ending July 2020. It also generated 32% of Biogen’s second quarter sales.
Back in August, Mylan also launched its own generic version of the same product after it was approved by the FDA on August 18.
“We note Cipla’s ANDA for Tecfidera obtained final approval this morning… we continue to see faster generic erosion than the Street may be appreciating and expect additional final ANDA approvals to follow shortly” commented RBC Capital’s Brian Abrahams on the news.
He has a hold rating on the stock with a $277 price target, citing the “likely more rapid than expected erosion of their core Tecfidera franchise.”
Shares in Biogen are currently trading down 5% on a year-to-date basis, and the stock scores a cautiously optimistic Moderate Buy consensus from the Street. That’s with 9 recent buy ratings offset by 15 hold ratings and 1 sell rating. Meanwhile the average analyst price target of $319 indicates 13% upside potential from current levels.
Meanwhile the next big catalyst for the stock is quickly approaching, with the FDA having just announced plans for an Ad Comm to discuss BIIB’s BLA for aducanumab to treat Alzheimer’s Disease on Nov. 6. (See BIIB stock analysis on TipRanks).
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