Tagged as: Allergan

ALJ Recommends Exclusion in Botox Trade Secret Case

We previously reported on an International Trade Commission hearing in a trade secret dispute brought by Allergan and Medytox against Daewoong and Evolus.  In the underlying investigation, Allergan and Medytox seek to block importation of Jeuveau® (prabotulinumtoxinA-xvfs), Evolus’s follow-on biologic to Allergan’s Botox® (onabotulinumtoxinA injection).  A one-page public notice provides…

Read More

Biosimilar Buyouts: AbbVie Buyout of Allergan Receives Approval of Irish High Court; Gedeon Richter Buys Tocilizumab Biosimilar

On May 8, 2020, AbbVie announced that it completed its acquisition of Allergan plc, having received approval by the Irish High Court.  AbbVie and Allergan had previously announced, on May 5, 2020, that the U.S. Federal Trade Commission accepted the proposed consent order in connection with the acquisition.  As part of…

Read More

AbbVie to Acquire Allergan for $63B

U.S.-based AbbVie, Inc. has reached a deal to acquire Irish pharmaceutical company Allergan PLC for about $63 billion, according to an AbbVie press release from Tuesday.  The “definitive transaction agreement” includes both cash and stock.  According to the press release, it is expected that, immediately after the closing of the…

Read More

Pipeline Updates: Pfizer, Amgen, and Allergan

Earlier this month, it was reported by the Regulatory Affairs Professional Society (RAPs) that Pfizer has terminated five biosimilar projects in preclinical development.  According RAPs, Pfizer’s Director of Global Media Relations, Thomas Biegi, said that resources from these programs would be reallocated “to late stage programs across Pfizer’s other key…

Read More

Evolus Announces Progress with Botox Follow-on Biologic

Last week, Evolus, Inc. announced updates to the regulatory progress of its BLA for DWP-450 (prabotulinumtoxinA), a follow-on biologic to Allergan’s Botox (onabotulinumtoxinA injection) product.  Evolus reported that FDA issued an Establishment Inspection Report (“EIR”) to Daewoong Pharmaceutical Co. Ltd., Evolus’s contract manufacturer for DWP-450.  According to Evolus, the EIR confirmed the…

Read More

Amgen/Allergan & Sandoz Receive Positive CHMP Opinions

Last week the Committee for Medicinal Products for Human Use (“CHMP”) of the European Medicines Agency (“EMA”) recommended two biosimilar medicines for approval. First, the CHMP adopted a positive opinion for the marketing authorization of Kanjinti® (ABP 980), Amgen and Allergan’s proposed biosimilar to Herceptin® (trastuzumab).  The CHMP opinion recommends…

Read More

Update on biosimilar launches and development

gloved hand withdraws drug solution with syringe

Sources are reporting that Korean pharmaceutical company Daewoong Pharmaceutical announced today that it has launched Samfenet, a biosimilar to Roche’s HERCEPTIN® (trastuzumab), in Korea.  Samfenet is priced at a 29.5-percent discount to Herceptin, which amassed around $6.5 billion in global revenue last year. Mylan announced last week that it has…

Read More