Tag Archives: Mylan

Biocon Insulin Manufacturing Facility Fails Another FDA Inspection

Biocon issued a press release stating it received a Form 483 with three observations following an FDA inspection (Feb 10-21) of its Malaysian manufacturing facility. The deficiencies were noted by FDA during the pre-approval inspection for the company’s biosimilar glargine. Recall, during Biocon’s recent earnings call, Biocon disclosed FDA has set an action date in June 2020. Below, FENIX provides brief thoughts on the failed inspection and how it could impact US commercialization of its bs-glargine product.

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Mylan Challenges Novo on Victoza Patent Dispute; Lexicon, Poxel, MannKind, and Diamyd Clinical Data

December 20, 2019

Mylan has challenged a patent for Novo Nordisk’s Victoza. Additionally, several diabetes players including Lexicon, Poxel, MannKind, and Diamyd have announced clinical results before the holiday break. Below, FENIX provides contexts and insights on these news items.

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Mylan and BD Q3 ’19 Earnings Updates

Mylan and Becton Dickinson hosted their respective Q3 ’19 earnings calls. Of note, Mylan provided a brief update on its insulin development program (in partnership with Biocon). Below, FENIX provides diabetes-related highlights and insights from the calls.

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Biocon CY Q3 ’19 (FY Q2 ’20) Earnings Update

Biocon hosted its CY Q3 ’19 (FY Q2 ’20) earnings call and briefly discussed its biosimilar insulin programs including bs-glargine, bs-aspart and bs-rHI. Recall, Biocon/Mylan received a CRL from FDA for bs-glargine submission in September 2019 (previous FENIX insight). Of note, Biocon indicated it is confident in resolving the CRL and anticipates FDA approval prior to the March 2020 insulin reclassification. Below, FENIX provides highlights and insights from the call.

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Mylan Faces Setback in Sanofi Bs-Glargine Lawsuit

According to new court documents, the presiding judge in the Sanofi v. Mylan glargine lawsuit has denied Mylan’s request to rule two Lantus formulation patents invalid. The trial to settle the ongoing patent dispute is scheduled to start on December 2, 2019. Below, FENIX provides thoughts on the judge’s ruling and the potential impact on the Mylan/Biocon bs-glargine US launch timeline.

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Biocon/Mylan Glargine CRL; BI/ZEAL Dual Agonist Moves to Ph2; Vertex Acquires Semma

Three key pieces of news have recently been observed: Biocon/Mylan received a CRL from FDA regarding their bs-glargine Malaysian manufacturing facility, Boehringer Ingelheim is advancing its dual agonist into Ph2 (licensed from Zealand), and Vertex entered into a definitive agreement to acquire Semma Therapeutics. Below, FENIX provides thoughts and insights on the respective news items including the uncertainty around Biocon/Mylan’s glargine in the context of the merger with Pfizer.

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Biocon’s Glargine Facility Receives EU GMP Certification

Yesterday, Biocon announced it received EU GMP certification from EMA for its integrated insulin facility in Malaysia, which was inspected in May 2019. Biocon’s Malaysian facility manufactures insulin glargine and rh-insulin. Below, FENIX provides additional thoughts on the EU GMP certification in the context of the recent FDA 483 observations and impending Biocon/Mylan bs-glargine US launch.

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Novo Sues Mylan Over Generic Victoza

Novo has filed a lawsuit against Mylan over Mylan’s ANDA Paragraph IV filing of a generic Victoza (view court documents here). In the complaint, Novo asserts that Mylan is infringing upon 7 Novo patents. Recall, during Novo’s Q2 ’19 earnings press release, Novo disclosed it received notice from Mylan regarding the generic Victoza ANDA filing but had not yet filed suit (previous FENIX insight). Below, FENIX provides brief thoughts on the Novo lawsuit including context from Novo’s recent settlement with Teva for its generic Victoza filing.

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Biocon CY Q2 ’19 (FY Q1 ’20) Earnings Update

Biocon hosted its CY Q2 ’19 (FY Q1 ’20) earnings call and briefly discussed its biosimilar insulin programs including bs-glargine and bs-aspart. Of note, Biocon recently initiated three Ph1 PK/PD studies for its rHI portfolio. Below, FENIX provides highlights and insights from the call.

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Biocon Malaysian Facility Receives Additional 483 Observations From FDA

Biocon has received an additional twelve 483 observations from an FDA inspection of Biocon’s Malaysian facility. The 483 observations were a result of an FDA pre-approval inspection for the bs-glargine product; however, the company did not provide any specific details. No result was found during a search of FDA’s inspection citations. According to Biocon, the inspection is not anticipated to impact plans for US commercialization. Below, FENIX provides context and insight regarding these 483 observations.

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