Global Markets

Roche looks to delivery device to keep Lucentis biosimilars at bay

Roche says its Port Delivery System will keep Lucentis (ranibizumab) competitive against upcoming biosimilar competition. Lucentis pulled in CHF 1.66 billion ($1.66 billion) in US sales for Roche in 2018, up 18% on the year before. The drug is marketed in Europe by fellow Swiss firm Novartis. The firm attributed the increase to the “ongoing rollout of prefilled syringes and sales increases in all approved indications.” The monoclonal antibody, approved for eye conditions including neovascular (‘wet’) age-related macular degeneration, macular…

Madison expansion will add commercial capacity, says Catalent

Plans to invest $200 million laid down last year will put Catalent in a position to offer commercial manufacturing from its Madison, Wisconsin facility, the CDMO says. In November 2018, contract development and manufacturing organization (CDMO) Catalent announced its intentions to invest across its two biomanufacturing sites. The board laid down plans to plough $100 million (€88 million) into its Madison, Wisconsin plant to add a fourth and fifth biomanufacturing train. During Catalent’s second quarter FY2019 financial call this week,…

Pfizer looks to oncology biosimilars to break US market

Biosimilar uptake in the US has been stifled in the inflammation and immunology (I&I) space but Pfizer expects a different dynamic for oncology products. Pfizer’s biosimilar business had a robust year in 2018. The firm reported a 41% operational growth in the sector over the year prior, with total sales of $769 million (€674 million). The company attributed much of this growth to sales of Inflectra, its version of J&J’s Remicade (infliximab), which pulled in $642 million worldwide including $259…

Vendors highlight another standout year for bioprocessing

Demand for bioprocessing technology remains strong as GE Healthcare, Thermo Fisher, Pall and Sartorius all report high annual growth. With the financial season in full swing, four of the major industry suppliers have reported their Q4s and end-of-year results, and all have one thing in common: high growth across their bioprocessing segments. GE Healthcare, which is being prepped to separate from parent company General Electric, reported revenues of $19 billion (€16.5 billion) for the full year, up 4%. The division…

Novartis: Manufacturing volumes a barrier to $10bn insulin space

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.…

Global Humira sales near $20bn, but expect decline in 2019

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 on track to bring follow-on Lantus to US in 2020

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…

Lower infliximab revenues but J&J still holds 93% share

There have been two infliximab biosimilars available in the US for over a year, but Johnson & Johnson says reference biologic Remicade still holds a 93% volume share. In 2016, Pfizer launched Inflectra in the US. The following year, Merck & Co. launched Renflexis. With the ensuing price war, the infliximab biosimilars had been touted to end reference biologic Remicade’s market dominance. But after the first full year with all three infliximab products on the market, J&J has reported in…

Lilly’s speedy $8bn Loxo buy ‘not competitive,’ says analyst

It took Eli Lilly 18 days from expressing its interest in Loxo Oncology to executing an $8 billion merger agreement. Being a “significant premium over the market price” and with no other bidders, the deal’s competitiveness has been questioned. Earlier this month, Eli Lilly announced it had agreed to buy Loxo Oncology for $235 (€206) per share in cash, totaling around $8 billion. The deal increases Lilly’s oncology portfolio, including lead candidate LOXO-292, an oral RET inhibitor being studied across…

Boehringer expanding China CDMO plant

Boehringer Ingelheim has begun an expansion at its biomanufacturing facility in Shanghai as it looks to tap the “great potential in China.” The expansion at the site in Shanghai covers an additional bioreactor and will include the necessary utility and infrastructure to support GMP operations of two 2,000 L single use bioreactor manufacturing lines. When asked, the Germany-headquartered firm did not divulge further details on the specifics of the investment. Boehringer Ingelheim spent more than €70 million in the first-phase…