Business

Profitability in the Biosimilars Market

The biosimilars space offers significant commercial opportunity. About US$60 billion of branded biologic sales will lose patent protection over the next few years, including some of the largest-selling monoclonal antibodies (MAbs). Companies are jostling among themselves, each seeking the best position to exploit that opportunity. Regulators are creating and refining the necessary pathways to success, alliances are being forged, and companies are being acquired. Despite the significant opportunity for biosimilar MAbs, significant risks remain. Perhaps the most significant of those…

An Analysis of the US Biosimilars Development Pipeline and Likely Market Evolution

No consensus concerning biosimilar-related terminology and definitions has yet been achieved (1,2,3). Biosimilars may be defined as biopharmaceuticals slated for generic-drug–like, abbreviated, comparisons-based approvals through a formal biosimilar approval pathway in the United States, European Union, and/or other highly regulated and developed countries based on a demonstration of substantial (bio)similarity to a reference product. As required in the United States, biosimilar active agents (those involving recombinant proteins) must be identical in primary sequence with their reference products. Analytical and comparative…

In Vitro Functional Testing Methods for Monoclonal Antibody Biosimilars

The pressure to contain rising healthcare costs — combined with the number of innovator biologic drugs coming off patent (30 licensed biological drugs by 2015) — offers huge opportunities for developers of biosimilar products. In 2011, the global market size of the biosimilars industry was around US$2.5 billion. Global demand for such products — and monoclonal antibody (MAb) biosimilars, specifically — is estimated to grow at 8–17% from 2012 to 2016 (1). The advent of biosimilars should bring more affordable…

Concerns, Collaboration, and Capacity

The BPI Theater is a 50-seat venue that for seven years has been located at the heart of the BioProcess Zone on the exhibition floor of the BIO International Convention. There, BPI provides attendees with four days of live presentations focusing on the latest scientific advances and business trends in biotherapeutic development and manufacturing. On Monday afternoon, 22 April 2013, Patricia Seymour of BioProcess Technology Consultants (BPTC) moderated a roundtable discussion on biosimilar development in the BPI Theater at BIO…

Biologics Have a Robust Pipeline

Earlier this year, the Pharmaceutical Research and Manufacturers of America (PhRMA) released a report titled 2013 Report: Medicines in Development – Biologics. It lists 907 biologics currently in development at “America’s biopharmaceutical research companies.” The list includes biologics targeting more than 100 diseases that either are currently in human clinical trials or are under review by the US Food and Drug Administration (FDA). Of those 907 product candidates, the most common types are monoclonal antibodies (MAbs, 338), vaccines (250), and…

Broadening the Baseline

When the editors of BPI asked us at BPSA to put together a content-rich article on single-use issues, we were happy to do so. Our challenge was how to bring in multiple viewpoints about the growing business of single-use that would be a “quick read” for the BPI audience. The answer: an expert colloquy. Represented here are several of the most qualified industry spokespersons in single-use — all are members of BPSA and speak as directors of the alliance. Their…

Better Cells for Better Health

Since its inception 35 years ago, the biennial meeting of the European Society for Animal Cell Technology (ESACT) has built on a tradition of combining basic science and applications into industrial biotechnology to become the international reference event in its subject matter. Every other year, this gathering of academics and industry professionals features a famously exciting social program and an extensive vendor/supplier exhibition specific to animal cell technology. ESACT meetings are much-anticipated international venues for information exchange, inspiration, networking, and…

The Role of Medical Affairs in Moving from R&D to Commercialization

Bringing a new pharmaceutical product to market is a unique process based on a number of requirements for supporting a product launch. For a research and development (R&D) company, launching a product into market may seem to be an issue for someone else to handle in the far-distant future and at a much later time. But even at laboratory or early development stages, biotechnology companies should understand the language of pharmaceutical companies and know how that industry operates. Doing so…

Broadening the Baseline

When the editors of BPI asked us at BPSA to put together a content-rich article for the single-use supplement, we were happy to do so. Our challenge was how to bring in multiple viewpoints about the growing business of single-use that would be a “quick read” for the BPI audience. The answer: an expert colloquy (a “conversational exchange or topical dialogue”). Represented here are several of the most qualified industry spokespersons in single-use — all are members of BPSA and…

Liquid or Powdered Media?

For decades, innovations in research and production techniques have been driving forces in the biopharmaceutical industry. But market conditions fueled by the economic downturn over the past five years have increased regulatory burdens in the United States and Europe. Rising costs and risks associated with new drug development now require that biopharmaceutical companies manufacture their products more quickly and cost-effectively than ever before. To this end, companies are looking for new ways to reduce expenditures, increase profitability, speed research, enhance…