Therapeutic Class

FDA paves way for insulin biosimilars, but will they be interchangeable?

Sanofi will see its short-acting follow-on insulin Admelog be regulated as a biosimilar from 2020 under US FDA plans to promote competition. But the need for additional studies to show interchangeability could delay any impact, the firm says. The US Food and Drug Administration (FDA) has been actively pursuing efforts to increase adoption of biosimilar products over the past year. In July, the Agency published a ‘Biosimilars Action Plan’ aimed at promoting access to lower-cost biosimilar drugs while maintaining a desire…

MacroGenics clinical hold has no wider implications for bispecifics, say analysts

The US FDA has placed a partial clinical hold on MacroGenics’ CD3 bispecific candidate MGD009 following reports of hepatic adverse events. On December 6, the US Food and Drug Administration (FDA) sent Maryland-based clinical-stage biopharmaceutical company MacroGenics a letter indicating that a partial clinical hold has been placed on its Phase I monotherapy study of MGD009 and a combination study of MGD009 and MGA012 (anti-PD-1). No new patients will be enrolled in either study until the partial hold is lifted…

PPD beefing up biologics lab services in Ireland

Contract research organization (CRO) PPD will expand its biologics capabilities in Athlone, Ireland to include cell and gene therapy analytical testing. The 41,000 square foot Athlone facility will have a further 6,000 square feet of lab space added to it to feed the demand for biologics testing and to mirror expansions being made at PPD’s facility across the pond in Middleton, Wisconsin. “The Athlone facility enables us to partner closely with a wide variety of both European and global clients…

Gilead hopeful for allogeneic IND next year

Gilead, which has already seen success with an autologous CAR-T therapy, says it hopes to submit an Investigational New Drug (IND) request for an off-the-shelf product in 2019. In August 2017, Gilead Sciences acquired Kite Pharma for $11.9 billion (€10.5 billion). Weeks later, the firm became only the second to receive US Food and Drug Administration (FDA) approval for a chimeric antigen receptor (CAR) T-cell therapy through the Kite-developed product Yescarta (axicabtagene ciloleucel). Yescarta is an autologous product, meaning it…

Belgian CDMO MaSTherCell doubles cell therapy capacity

MaSTherCell will be able to manufacture about 1,000 batches a year through the expansion, helping to feed the high demand for cell therapy production. The contract development and manufacturing organization (CDMO) unveiled a 600 m2 wing at its site in Gosseles, Belgium, effectively doubling its cell therapy production capacity through five extra clean rooms. “Each clean room is about 30 m²,” Romain de Rauville, head of Business Development Europe at MaSTherCell, told this publication. “The capability depends on the process…

Amgen on Soliris: Low patient population but high biosimilar potential

The high cost of Alexion’s ultra-orphan disease MAb Soliris (eculizumab) drove Amgen’s decision to develop a biosimilar version, says SVP of Global Development Elliott Levy. Soliris (eculizumab) is an approved treatment for orphan diseases paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (a-HUS) treatment. The monoclonal antibody (MAb) was – until the arrivals of CAR-T and gene therapies Kymriah, Yescarta and Luxturna last year – the most expensive drug in the world, and netted Alexion $3.1 billion (€2.8 billion)…

Axovant looks to CDMO Yposkesi for gene therapy scale up

Axovant Sciences has selected French CDMO Yposkesi as a strategic partner to help bring its neurologic and neuromuscular gene therapy candidates through the clinic. Contract development and manufacturing organization (CDMO) Yposkesi will utilize its adeno-associated virus (AAV) and lentiviral vector production capabilities to service the strategic agreement with Axovant. Swiss biotech Axovant has a pipeline of gene therapies targeting neurological and neuromuscular diseases. Financial details have not been divulged, but Alain Lamproye, CEO of Yposkesi, said it is a straight…

Teva settle with Roche to launch first Rituxan biosimilar in US

Truxima becomes the 15th biosimilar, and the first version of Rituxan (rituximab), to be approved in the US. A settlement agreement with Roche will allow Teva to market the product but the launch date has not been revealed. The US Food and Drug Administration (FDA) gave the thumbs up to Truxima this week, making it the first biosimilar version of Roche/Genentech’s Rituxan to be approved in the US. The product is manufactured by South Korean firm Celltrion but will be…

Aji Bio enters ‘rapidly growing’ ADC space

Ajinomoto Bio-Pharma Services has launched a bioconjugation technology it says has high productivity and short conjugation reaction times. According to contract development and manufacturing organization (CDMO) Aji Bio-Pharma, its AJICAP technology lets antibody-drug conjugates (ADC) developers better control the location of payload conjugation to an antibody and fine tune the quantity of payload attached. “The technology deploys a proprietary affinity peptide to direct controlled conjugation to a specific sites on the antibody in a relatively straight forward synthetic process,” Jason…

Boehringer Ingelheim abandons biosimilars outside the US

German drugmaker Boehringer Ingelheim will not commercialize its approved adalimumab product Cyltezo in Europe and is discontinuing all biosimilar development activities outside the US. Earlier this month, an article published in Bioprocess Insider considering the impending exit of Big Pharma from the biosimilars space brought a lot of attention from industry and investors. The piece drew on Merck KGaA’s abandonment of its biosimilars programs in 2017 as an example, and now fellow German Big Pharma firm Boehringer Ingelheim is contemplating…