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Mylan Gets Complete Response Letter For Biosimilar Neulasta


Mylan N.V. MYL suffered a setback following the FDA’s Complete Response Letter (CRL) for the company´s Biologics License Application (BLA) for MYL-1401H, a proposed biosimilar of Amgen’s Inc. AMGN Neulasta.

The CRL relates to the pending update of the BLA with certain CMC data from facility requalification activities post recent plant modifications.

However, the CRL did not raise any questions on biosimilarity, pharmacokinetic/pharmacodynamic data, clinical data or immunogenicity.

Mylan is exploring the world of biosimilars, a market that has the potential to grow to $20 billion in 2020. A partnership with Biocon, and additional collaborations has helped Mylan develop a wide portfolio of biosimilar/insulin analog generic products, representing a total brand market value of more than $75 billion in worldwide sales.

Earlier, the FDA notified Mylan and partner Biocon that the target action date for a biosimilar version of Roche Holding AG’s RHHBY Herceptin (trastuzumab) has been extended to Dec 3, 2017. A decision from the FDA was expected by Sep 3 but the review period was extended due to some of the clarificatory information that were needed to be submitted to the agency as part of the process.

Last week the FDA approved the generic version of Teva Pharmaceutical Industries Limited’s TEVA multiple sclerosis drug Copaxone (glatiramer acetate) 40 mg/mL (thrice weekly).

The news boosted investors’ sentiment and the company’s shares surged on the same. Mylan’s stock has increased 1.1% in the last six months compared with the industry’s decline of 17.4%.

Notably, this is the first generic of Copaxone that has been approved. The FDA also approved a generic for Copaxone 20 mg/mL once-daily. Since Mylan was one of the first applicants to submit a substantially complete ANDA for glatiramer acetate Injection, 40 mg/mL, containing a Paragraph IV certification, the company and other first filers may be eligible for 180 days of generic drug exclusivity. According to QuintilesIMS, sales of Copaxone 20mg/mL dose was approximately $700 million and $3.64 billion for the 40 mg/mL dose for the 12 months period ending July 31, 2017. Hence, the generic approval is expected to provide a significant boost to Mylan.

Zacks Rank

Mylan currently carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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