The manufacturing volumes needed to succeed in the insulin market are huge says Novartis, fresh from entering the space through a biosimilars partnership. Late last year, Swiss pharma firm Novartis, through its division Sandoz, partnered with Chinese manufacturer Gan & Lee in an effort to bring biosimilar insulins to the US and Europe. Sandoz told this publication at the time that Gan & Lee’s production capacity, “with attractive cost of goods sold structures,” was a major driver to the collaboration.…

Looking to 2019, AbbVie says US sales of its bestseller monoclonal antibody Humira (adalimumab) will continue to grow but expects a $2 billion hit from biosimilar competition. For the full year 2018, AbbVie reported total sales of $32.8 billion (€28.7 billion), comprising $19.9 billion in sales of the world’s most successful drug by revenue, Humira (adalimumab). This represented a 7.4% year-on-year growth for the monoclonal antibody (MAb). But for AbbVie, 2018 was tainted by the approval and launch of several…

Biocon says it expects US approval of its follow-on insulin glargine referencing Lantus by March 2020 despite a Sanofi lawsuit and manufacturing concerns. In June 2018, Indian drugmaker Biocon acknowledged a complete response letter (CRL) from the US Food and Drug Administration (FDA) for its insulin glargine product, submitted under the 505(b)(2) ‘follow-on’ regulatory pathway. The product has received approval in Europe and other regions as a biosimilar to Sanofi’s Lantus, under the name Semglee. At the time, a spokesperson…