Mylan’s Lantus biosimilar held up by manufacturing issue

pharmaphorum | September 03, 2019

Mylan’s hopes of grabbing a slice of the big US market for insulin glargine – the active ingredient in Sanofi’s Lantus blockbuster – have been dealt a blow. The FDA has issued a second complete response letter (CRL) rejecting the marketing application for the biosimilar after uncovering quality problems at Biocon – Mylan’s partner for the drug – in a pre-approval inspection of one of its manufacturing facilities in Malaysia. Biocon played down the implications of the compliance issue, saying in a statement that it doesn’t expect “any impact of this CRL on the commercial launch timing of our insulin glargine in the US” and that the FDA had no “outstanding scientific issues” with the marketing application. It is however a near carbon-copy of the situation last year when the FDA issued its first CRL for the product, once again because corrective actions were needed at a Malaysian plant. Mylan, which is due to merge with Pfizer’s Upjohn unit next year, is trying to bring the second Lantus copycat to market in the US after Eli Lilly and Boehringer Ingelheim’s Basaglar, which was approved by the FDA in 2014 and launched under an agreement with Sanofi at the end of 2016. It hasn’t released a statement on the latest CRL. Sales of Lantus were around €6 billion (around $6.5 billion) at their peak but started to decline in 2014 after the first biosimilars were approved in Europe, and as downward pressure on insulin prices in the US started to take hold.

Spotlight

It is important to control the level of endotoxin units in materials used in the production of drug products and medical devices, especially those that cannot undergo depyrogenation.

Spotlight

It is important to control the level of endotoxin units in materials used in the production of drug products and medical devices, especially those that cannot undergo depyrogenation.

Related News

PHARMA TECH

Cambrex Completes First Phase of $30 Million Capacity Expansion Project in High Point, North Carolina

Cambrex | September 05, 2022

Cambrex today announced the completion of the first phase of its $30 million investment in its small molecule active pharmaceutical ingredient manufacturing facility in High Point, North Carolina. The newly constructed space adds analytical and chemical development laboratories totaling 30,000 square feet and provides future workspace for 85 analytical and chemical development scientists. These laboratories will support the development of APIs to be manufactured in the facility's current clinical manufacturing area, as well as the future expanded clinical manufacturing and commercial manufacturing suites. "With the growing number of therapies in clinical development and trend toward more targeted therapeutics, including orphan drugs, this expansion is preparing Cambrex to support the growing demand for small-scale API manufacturing. Our expansion goes beyond providing capacity – it provides state-of-the-art technology and laboratory equipment, an energy efficient infrastructure, and an ideal space for our scientific experts to work side-by-side with our clients." Tom Loewald, CEO, Cambrex Phase 2 of the project is ongoing and will approximately double the facility's manufacturing capacity with the addition of clinical and commercial manufacturing suites with reactors up to 2,000 liters. The new commercial area will provide an ideal scale for the manufacturing of orphan drugs and niche therapies, while larger volume products developed at the facility can be manufactured commercially at one of Cambrex's larger scale facilities in Iowa and Sweden. This expansion follows Cambrex's 2021 investment in the Cambrex High Point continuous flow R&D center of excellence, including expanded capabilities for continuous flow process development, manufacturing, and scale up. Cambrex continues to expand its capabilities and capacity across its North American and European network to meet the growing demand for outsourced product development and manufacturing services. About Cambrex Cambrex is a leading global contract development and manufacturing organization that provides drug substance, drug product, and analytical services across the entire drug lifecycle. With over 40 years of experience and a growing team of over 2,300 experts servicing global clients from North America and Europe, Cambrex is a trusted partner in branded and generic markets for API and finished dosage form development and manufacturing. Cambrex offers a range of specialized drug substance technologies and capabilities, including biocatalysis, continuous flow, controlled substances, solid-state science, material characterization, stability storage, and highly potent APIs. In addition, Cambrex can support conventional dosage forms, including oral solids, semi-solids, and liquids, and has the expertise to manufacture specialty dosage forms such as modified-release, fixed-dose combination, pediatric, bi-layer tablets, stick packs, topicals, controlled substances, sterile, and non-sterile ointments.

Read More

BUSINESS INSIGHTS

Astellas and MBC BioLabs Announce Astellas Future Innovator Prize to Help Biotech Start-ups Accelerate Early Drug Discovery and Research Efforts

Astellas Pharma Inc. | September 20, 2022

Astellas Venture Management LLC a wholly-owned venture capital subsidiary of Astellas Pharma Inc. and Mission Bay Capital BioLabs a life-science incubator, today announced their collaboration on the "Astellas Future Innovator Prize" formerly known as the Astellas Golden Ticket competition. Building on over three successful years, the competition offers entrepreneurial scientists or emerging biotechnology start-ups one year's priority usage of MBC BioLabs' state-of-the-art lab facility and access to Astellas' research and development (R&D) capabilities and business leaders. With a shared commitment to discovering and advancing innovative science for the potential future benefit of patients worldwide, AVM and MBC BioLabs are continuing their partnership to support scientists and early-stage companies to accelerate their novel therapeutic programs, modalities or platforms. The 2022 competition will prioritize innovative research that compliment Astellas' Focus Area Approach and pipeline. "We are truly thrilled to host the Astellas Future Innovator Prize again this year. Through our long-term collaboration with MBC BioLabs, we aim to create an environment that encourages innovation to thrive. The Astellas Future Innovator Prize enables us to provide biotech companies with expertise and capabilities to turn an innovative idea into a real solution, which could transform the lives of patients in need around the world." William Watt, President, AVM "We are pleased to continue our partnership with Astellas to uncover the innovators of tomorrow," said Douglas Crawford, MBC BioLabs General Manager. "The past winners of the Astellas Future Innovator Prize show what can be achieved by combining Astellas' support, advice and expertise with our laboratory incubator, and we are excited to see the result of our ongoing collaboration." Entrepreneurial scientists, emerging life-science and biotechnology start-ups have until November 4, 2022 to enter the Astellas Future Innovator Prize. About the Astellas Future Innovator Prize at MBC BioLabs Astellas is offering up to two prizes for pioneering scientists with innovative research that complements Astellas' areas of interest in alignment with its Focus Area Approach and pipeline, including Blindness & Regeneration, Mitochondria, Genetic Regulation, Immuno-Oncology, Cell Therapy, and other areas. The 2021 Astellas Future Innovator Prize winners were Vcreate and Weatherwax Biotechnologies, chosen for the potential of their innovations to deliver therapeutic advances for unmet medical needs and their potential synergy with Astellas' Focus Area Approach. About Astellas Venture Management LLC AVM is the wholly-owned venture capital organization within Astellas, dedicated to supporting pre-clinical, cutting-edge science that can bring VALUE to patients. For over 15 years, AVM has provided equity investments to private, early-stage companies developing therapeutic programs and platform technologies, helping them to advance their innovations faster. AVM is a strategic investor, making investments in science that will enhance the current Astellas R&D pipeline or that could catalyze new directions in discovery research. About Astellas Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are promoting the Focus Area Approach that is designed to identify opportunities for the continuous creation of new drugs to address diseases with high unmet medical needs by focusing on Biology and Modality. Furthermore, we are also looking beyond our foundational Rx focus to create Rx+® healthcare solutions that combine our expertise and knowledge with cutting-edge technology in different fields of external partners. Through these efforts, Astellas stands on the forefront of healthcare change to turn innovative science into value for patients. About MBC BioLabs MBC BioLabs is dedicated to helping life-science startups succeed. By renting space as small as a single bench and providing these entrepreneurial scientists with access to millions of dollars of equipment, MBC BioLabs allows companies to be fast, focused, and frugal. It has three sites: one in the Dogpatch neighborhood in San Francisco and two campuses in San Carlos, California. Each site has a complete molecular biology core facility that allows companies to do experiments on day one. MBC BioLabs has partnerships with leading pharmaceutical and life-science companies as well as a built-in venture capital firm, Mission BioCapital. These partnerships provide entrepreneurs with valuable insights about where to focus their efforts and accelerates the innovation pipeline. Since opening in 2013, MBC BioLabs has helped launch and grow 290 companies. These companies have brought 58 programs to the clinic, produced 13 approved diagnostics, and raised over $14 billion.

Read More

BUSINESS INSIGHTS

Mikart and Nano PharmaSolutions have entered into a collaboration agreement to manufacture clinical trial materials using NanoTransformer™ Technology

Mikart, LLC Nano and PharmaSolutions, Inc. | October 12, 2022

Mikart, LLC a comprehensive contract development and manufacturing organization announced that it has entered into a collaboration agreement with Nano PharmaSolutions, Inc. an innovative nanotechnology company that has a proprietary NanoTransformer™ that enhances the solubility of pharmaceutical active ingredients. "We are excited to bring this new technology from preclinical stage to a GMP clinical phase manufacturing environment. This differentiated, solvent-free, nano-granulation process for drug development and manufacturing provides our customers with an alternative solubility enhancement technology." Nazar Elkarim, PhD, Vice President of Pharmaceutical Development Services at Mikart Kay Olmstead, PhD/MBA, Chief Executive Officer at NPS, added, "Nano PharmaSolutions is excited for this collaboration which will provide us with GMP manufacturing capabilities for development of nanomedicines, using our NanoTransformer™ technology at Mikart's facility." Louis Weber, Vice President of Business Development at Mikart, added, "Mikart is committed to offering innovative options for enhancing solubility and bioavailability to our customers. We feel this nanotechnology will further enhance our development, clinical, and commercial capabilities designed to bring value to our growing customer base." About Mikart, LLC Mikart, LLC is a privately held contract development and manufacturing organization founded in 1975. Mikart focuses on small molecules, potent compounds, solid oral, combination products, suspensions, liquids and serialized packaging services. The company has a full range of formulation, analytical, packaging and manufacturing services with a seamless development solution that minimizes the time-to-market from clinical work through commercial supply. About Nano PharmaSolutions, Inc. Nano PharmaSolutions, Inc. developed a NanoTransformer™ technology that generates nanoparticles of active pharmaceutical ingredients with physical vapor deposition (PVD), a nanocoating method without using any polymers or solvents. This robust and high drug loading technology increases bioavailability of poorly soluble drugs. The NanoTransformer™ Technology produces patient-centric dosage forms while accelerating drug candidates to the clinic by shrinking development time and R&D costs.

Read More