Global Markets

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…

Lonza adding single-use capacity and 180 jobs at UK mammalian plant

Lonza will increase its mammalian process development and small-scale cGMP manufacturing capabilities through a multi-million pound investment at its Slough, UK site. Swiss contract development and manufacturing organization (CDMO) has told BioProcess Insider it is making a “multi-million pound investment” into its facility in Slough, UK. The site, located around 40km west of London, serves as Lonza’s center of excellence for mammalian biopharmaceutical process development and small-scale cGMP manufacturing, primarily for clinical phases. It also offers a range of analytical…

Beyond Humira: AbbVie looks to $35bn pipeline for future growth

With the world’s best-selling drug now facing direct biosimilar competition, AbbVie says it is confident its robust pipeline will deliver double-digit growth going forward. In 2018, the first biosimilar versions of Humira (adalimumab) were launched in Europe and other non-US markets. Meanwhile in October, Sandoz became the third firm to receive US Food and Drug Administration (FDA) approval for a Humira biosimilar. It is, therefore, fair to say sales of the world’s top selling drug – Humira clocked in sales…

Third Korean plant with 120,000L capacity back on for Celltrion

Celltrion has confirmed its third biomanufacturing plant will be constructed in Korea after assessing locations overseas. The facility will have 120,000 L of biologics capacity. Seo Jeong-jin, chairman of Korean drugmaker Celltrion, told investors at last year’s JP Morgan Healthcare Conference that plans laid down in 2016 to build a third biomanufacturing facility at its site in Songdo, Incheon had been scrapped in favor of a much larger facility overseas. But a year on and Celltrion has announced a U-turn.…

China’s biotech growth drives Pall center of excellence in Shanghai

Pall has established a Center of Excellence in Shanghai, China to service a biotech sector it says is worth $500 million and set to grow by double-digits. Bioprocessing vendor Pall has several centers of excellence (CoE) set up globally to showcase its biomanufacturing offerings and has now opened a center in Shanghai to service the Chinese market. “The goal of the CoE is to facilitate training and adoption of the advanced manufacturing technologies that will improve the productivity and robustness…

UK must avoid no-deal Brexit, says British pharma group

Crashing out of the European Union without a deal will be catastrophic, says the head of the Association of British Pharmaceutical Industry (ABPI) Mike Thompson.  However, the pharmaceutical industry is stockpiling medicines in preparation, he confirmed. As the UK braces itself for an unprecedented and potentially calamitous exit from the European Union (EU) on March 29th, firms including Pfizer, Merck & Co, and Sanofi, as well as UK-headquartered GlaxoSmithKline and AstraZeneca, have reportedly been stockpiling medicines. This was confirmed today by…

BMS $74bn Celgene deal to create ‘number one oncology franchise’

The acquisition of Celgene will boost Bristol-Myers Squibb’s commercial portfolio and clinical pipeline and create synergies of $2.5 billion, the firm says. The new year has started with an M&A bang, with pharma giant Bristol-Myers Squibb (BMS) announcing its intentions to acquire its immune-oncology partner Celgene in a deal valued at $74 billion (€65 billion). According to Giovanni Caforio, CEO of Bristol-Myers Squibb, four value areas drove the merger. The first is creating leading franchises in oncology, immunology and inflammation…