Stephanie Sutton was an assistant editor at Pharmaceutical Technology Europe.

Stephanie Sutton

 its guidance on biosimilar medicines, with the aim of helping companies to avoid unnecessary repetition of clinical trials. In particular, the guidance enables companies to submit batches of reference medicines that have been sourced from outside of the European Economic Area (EEA). 

The changes will come into effect following the revisions of the EMA’s guidelines on similar biological medicinal products, which is expected to be released as a draft for public consultation in early 2013.

Currently, companies developing a biosimilar must use a reference product that is authorized in the EEA. All batches of the reference medicine must also be sourced from the EEA, which often requires companies to repeat all clinical studies with batches sourced from various locations. In the past, this approach had helped to ensure reliable comparability. 

When the changes come into effect, companies will be responsible for performing analytical comparisons to ensure that the batches used are representative of the EEA-authorized reference medicine. Companies may also need to supply comparative pharmacokinetic and pharmacodynamic data.

The new approach to biosimilars was first announced by Commissioner John Dalli in June 2012. EMA was the first regulatory authority to establish a comprehensive framework for biosimilars in 2005. However, the development of biosimilars has become an increasingly global business, with many countries having now established biosimilars legislation similar to Europe’s. According to Dalli, these developments have allowed the European Commission to revise the interpretation of its biosimilars guidelines to accept biosimilar applications that contain clinical data with reference products not sourced from the EEA.

Because the changes of interpretation are made based on the existing legislation, it means there will not be a lengthy legislative process. 

Articles

The European Medicines Agency has updated its guidance on biosimilar medicines, with the aim of helping companies to avoid unnecessary repetition of clinical trials.

EMA Aims to Facilitate Biosimilars Development

	At the inaugural joint FDA/ISPE conference on CGMP earlier this year, the FDA’s Dr. Janet Woodcock delivered a strong message to the pharmaceutical industry: the efforts to adopt Quality by Design (QbD) principles within pharmaceutical manufacturing must be a top priority for the industry. She put the onus on industry and regulators to find ways to work together more effectively, to engage in productive conversations, and to dissolve roadblocks to QbD and the issues that lead to counterfeiting, shortages, and other threats to safe, high-quality medicines.

	ISPE has made an increased focus on pharmaceutical quality a keystone of a new direction for the Society. While our Members have always worked to find and solve technical problems they faced on the job, it is no longer enough to focus on individual job or business functions. The industry needs a holistic approach, one that considers the entire product lifecycle, if it is to move past the issues that have kept it behind the curve in terms of manufacturing best practices. That is the mission ISPE has aligned behind, and it’s the mission that has shaped the conference program for the upcoming 2012 ISPE Annual Meeting.

	A key element of ISPE’s mission is greater interaction between pharmaceutical professionals and the global regulators who are responsible for ensuring drug safety. To help facilitate the types of high-level discussions that must take place between these two groups, the FDA’s second-highest official, Deputy Commissioner for Medical Products and Tobacco Dr. Stephen Spielberg, will deliver a plenary address on how the FDA is addressing challenges and taking advantage of opportunities to advance regulatory science through collaboration with associations like ISPE. We’ve also assembled an impressive number of regulators from every major international pharmaceutical marketâNorth America, Europe, Asia and Latin Americaâfor an International Regulatory Summit. The summit will feature a discussion on regional regulatory challenges and an examination of those challenges within the context of a global regulatory environment. A question-and-answer session will allow for open exchanges between the audience and the panel to candidly discuss real-world issues in face-to-face interactions that are essential for fostering closer working relationships between industry and regulators.

	Openness and candor are also important to addressing pharma’s challenges. Since I began at ISPE, I’ve been impressed by the degree to which our Members are willing to work together on solutions to technical issues they are facing. ISPE’s renewed focus means that we must bring those open conversations to ever-larger audiences and in ever-more-visible ways. At our 2012 Annual Meeting, our Executive Program Series will put these conversations on a global stage. In this education track, distinguished leaders from top pharma companies, contract manufacturing organizations and suppliers will discuss key issues identified by technical professionals as vital to the future of the industry. In talks such as Johnson & Johnson Vice President of Brand Protection Ron Guido’s “Confessions of a Counterfeiter,” the industry will take large strides towards fulfilling Dr. Woodcock’s directive to out its inconsistencies and make real progress towards getting to the heart of the industry’s toughest questions.

	Dr. Woodcock’s words at the CGMP event did not fall on deaf ears; ISPE and its Members understand that change for pharmaceutical manufacturing is long overdue, and that we must act now to attack problems that have been long in the making. Our 2012 Annual Meeting program is designed to give the industry the tools it needs to foster global changes and continue to ensure safe, available drugs for patients around the world.

At the inaugural joint FDA/ISPE conference on CGMP earlier this year, the FDA’s Dr. Janet Woodcock delivered a strong message to the pharmaceutical industry: the efforts to adopt Quality by Design (QbD) principles within pharmaceutical manufacturing must be a top priority for the industry.

ISPE Annual Meeting Seeks to Foster Global Change

Sanofi is planning to shed approximately 900 jobs in France in the lead up to 2015 as it seeks to implement certain key strategic objectives.

, Sanofi explained that reduction measures could involve early retirements, mobility proposals and repositioning within France. No relocation of sites or any changes to the number of industrial sites is planned in France; however, the company also added that the function of its Toulouse site “remains to be specified”. Over the summer, the company identified potential stakeholders who could maintain the site’s scientific or technological capacity and a working group will be established shortly to explore all available options. The company hopes to have a firm solution for the site within the coming months.

The workforce reduction is being undertaken to achieve three strategic objectives that the company first revealed at the beginning of July 2012. Sanofi is seeking to improve the momentum and success of research activities; improve the economic performance of Sanofi Pasteur’s industrial units; and streamline support functions. 

In the led up to 2015, Sanofi intends for its R&D activities in France to evolve to strengthen the company’s scientific, academic and private network. Plans include progressively adapting the Montpellier site into a strategic centre focused on development, and increasing research activities in Vitry/Alfortville and Chilly-Mazarin/Longjumeau. In addition, Sanofi intends to create a global center of excellence in infectious diseases in Lyon.

Sanofi to Cut 900 Jobs

The European Medicines Agency (EMA) has abolished its Cell-based Product Working Party (CPWP) and Gene Therapy Working Party (GTWP), with the aim of improving efficiencies and optimizing the use of available expertise.

Instead, EMA’s Committee for Advanced Therapies (CAT) will be assuming the lead role in all aspects concerning the development of advanced-therapy medicines in Europe, including developing guidelines, organizing workshops and establishing ad-hoc draft groups as and when required to develop specific guidance documents. Guidance documents already being developed by CPWP or GTWP will be taken over by the new drafting groups.

 from EMA, the move will strengthen the role of CAT as Europe’s reference body for advanced-therapy medicines. The Agency also thanked the members of CPWP and GTWP for their work over the past few years.

When establishing draft groups, approximately five experts will be drawn from CAT’s members and the European expert list. However, the current members of CPWP and GTWP will remain on consultation list for whenever their expertise is required.

CPWP and GTWP both existed prior to the establishment of CAT in 2009 and originally belonged to EMA’s Committee for Medicinal Products for Human Use. The parties were transferred once CAT initiated operational activities. 

The European Medicines Agency has abolished its Cell-based Product Working Party and Gene Therapy Working Party, with the aim of improving efficiencies and optimizing the use of available expertise.

EMA Streamlines Working Parties

	Yesterday, Sanofi issued a press statement titled “Sanofi provides information on the adaption of its activities in France through 2015.” Read past the headline and you quickly realise that the ‘adaption of activities’ involves eliminating around 900 jobs at the company’s sites France by 2015. You can read the statement 

	Job cuts are always a concern and the pharmaceutical industry has seen a large number of redundancies in recent years. According to newspaper reports, Sanofi alone has axed more than 4000 jobs since 2008. However, yesterday’s announcement could have been much worse. According to an article published by 

, trade unions had originally estimated that the company could shed up to 2500 jobs. An updated 

 explains that the lower-than-expected number could have come about through government pressure on the company to retain as many workers as possible.

	The reason for the workforce reduction is to help implement certain strategic objectives by 2015. Sanofi is looking to implement the changes mainly through voluntary measures and the cuts will primarily comprise of early retirements, mobility proposals and repositioning within France. The press statement explicitly states that no relocation of sites or changes to the number of industrial sites is planned in France.

	Unfortunately, there may be more to come as Sanofi also adds that the function of its Toulouse site “remains to be specified” and indeed the mention of the site is vague in the press statement. It was reported in July by various sources, including 

, that Sanofi was planning to close the site. Over the summer, Sanofi says it has identified potential stakeholders who could maintain the site’s scientific or technical capacity, and a working group will soon be created to explore the available options. “Concrete solutions” are hoped for within the coming months.

	Sanofi is aiming to achieve three strategic objectives: establish new momentum for success in R&D, improve the economic performance of the industrial units of Sanofi’s vaccine division, Sanofi Pasteur, and streamline support functions.

	With regards to R&D activities, Sanofi said in its statement that development activities in Vitry/Alfortville, CHilly-Mazarin/Longjumeau and Lyon will continue in their current configuration, with research in the former two locations being increased. Meanwhile, the company’s Montpellier site will evolve towards a strategic center focused on development, while the site in Strasbourg will maintain its position as a collaborative platform that is open to academic research and biotechnology companies. In Lyon, the company also hopes to create a “center of excellence” in infectious diseases.

	Those working for Big Pharma seem to be seeing a constant roll of redundancies. Let’s hope that whatever plan Sanofi finds for its Toulouse site is the best to ensure the minimum loss of jobs.

Yesterday, Sanofi issued a press statement titled “Sanofi provides information on the adaption of its activities in France through 2015”.