Stephanie Sutton was an assistant editor at Pharmaceutical Technology Europe.

Stephanie Sutton

The global market for biosimilars is set to grow from $243 million in 2010 to $3.7 billion in 2015, according to research from 

, an independent industry analyst company. 

One of the key drivers for growth will be the loss of patent exclusivity for many branded products. More than 30 branded biologics with sales of $51 billion will lose patent exclusivity by 2015, according to a 

from Datamonitor, which will pave the way for biosimilars. 

“With the market shares of first-generation biologic drugs stagnating or declining, biosimilar MAbs and second-generation biosimilars represent a high-value proposition for biosimilars manufacturers and key drivers for future growth,” Mark Hollis, healthcare analyst at Datamonitor, explained in the statement.

However, Hollis also warned that there a number of barriers to achieving commercial success with biosimilars in the developed markets, even though biosimilar approval pathways are now in place in Europe, Japan and the US. In 2009, 

According to Datamonitor, existing biosimilars are well-positioned to take advantage of the predicted market growth because they already have an industry reputation, as well as relationships with key stakeholders. However, branded pharma companies may also be looking to leap into the biosimilars arena as a way of increasing sales. Partnerships and M&As are potential ways of achieving this.

Consequently, Datamonitor believes that the future biosimilars market will continue to be dominated by existing biosimilars players, with the addition of select, branded pharma companies.  Companies in emerging markets may also make an appearance. Datamonitor adds: “Furthermore, emerging market biosimilars players are now looking to expand into global markets too, through partnerships with international pharma companies.”

Articles

The global market for biosimilars is set to grow from $243 million in 2010 to $3.7 billion in 2015, according to research from Datamonitor, an independent industry analyst company.

Biosimilars Market will be Worth $3.7 Billion by 2015

Novartis has completed the acquisition of a majority stake in Zhejiang Tianyuan Bio-Pharmaceutical Co., Ltd. — one of the largest privately held vaccines companies in China. The acquisition gives Novartis an expanded presence in the Chinese vaccines market and will facilitate the introduction of Novartis vaccines into the country.

"This agreement combines the strength of our vaccines R&D strategy and pipeline with Tianyuan's deep knowledge of the vaccines market in China," Andrin Oswald, Head of Novartis Vaccines and Diagnostics, said in a 

According to the statement, Novartis will collaborate with Tianyuan to strengthen its vaccines portfolio and pipeline, as well as align production processes and quality standards. Novartis also added that it plans to explore new vaccine developments to address unmet medical needs in China.

Ding Xiaohang, Founder, Chairman and CEO of Tianyuan, also added: "We have already identified several joint development programs that could be implemented in China over the next ten years, with the potential of launching key products responding to unmet medical needs in the mid-term."

In related news, Novartis has also reportedly announced that it will axe more than 500 positions in the UK at its Horsham site in West Sussex. The full story is available via 

Novartis has completed the acquisition of a majority stake in Zhejiang Tianyuan Bio-Pharmaceutical Co., Ltd. &#151; one of the largest privately held vaccines companies in China.

Novartis Acquires Chinese Vaccine Company

The EMA has announced a pilot program with the FDA for the parallel assessment of Quality by Design applications, as well as a separate project aimed at improving the agency’s core business.

The pilot with the FDA will commence on Apr. 1, 2011 and run for three years until Mar. 31, 2014, applying to selected applications submitted to both agencies at the same time. Both agencies will separately assess the parts of the applications relevant to QbD, including development, design space and real-time release testing, with regular communication and consultation throughout the process. The aim is to have a common list of questions for the applicant and a harmonised evaluation of responses.

In Europe, the pilot will apply to new marketing authorisation applications and quality-related scientific advice requests; Type II variations may also be included on a case-by-case basis. In the US, the pilot will apply to new drug marketing applications, prior-approval supplements and chemistry manufacturing control meeting requests. The pilot will only include chemical entities, but a 

 added that ongoing consideration would also be given to other areas of collaboration. 

A second project was also announced by the EMA this week to enhance the processes of its core business and to help boost the quality of certain applications. According to a 

, the project responds to one of the objectives of the EMA’s previously announced 

“The programme aims to improve the efficiency of processes in order to support the agency’s capabilities to deliver sustainable results. The program will initially focus on processes for the authorisation, supervision and maintenance of medicinal products to increase internal efficiency while maintaining quality of opinions and satisfaction of applicants,” said the EMA statement. 

Improvements will stem from identification and elimination of internal process complexity. However, the EMA also believes that significant improvements in throughput and lead times can be improved if applications are submitted to the agency in the highest possible standard. To help improve the efficiency of processes, the EMA has said it will provide a prenotification checklist to help applicants submit complete and correct type IA variation notifications, with the aim of raising the quality of these applications. 

The EMA has announced a pilot program with the FDA for the parallel assessment of Quality by Design applications, as well as a separate project aimed at improving the agency?s core business.

Pilot Assessments And Improvements At The EMA

 on Mar. 21, 2011, the EMA Management Board gave its approval for the current activities of former executive director Thomas Lönngren.

Lönngren, who stepped down on Dec. 31, 2010, came under fire from several organisations that claimed that his move to a new position as an advisor to the private pharmaceutical sector might have breached 

, dated Feb. 25, 2010, expressed concern that “there was no ‘cooling off’ period between his former and current employment."

Though the EMA Management Board approved Lönngren’s recent appointments, it was quick to state that it took the agency’s role in protecting the public interest and maintaining a good reputation seriously.

The board based its decision on two factors: “Firstly, whether any activity risked the misuse of confidential or privileged information gained during his leadership of the Agency and secondly whether any activity risked improper influence on decisions taken by the Agency.” The board concluded that no risk was posed, but expressed regret at Lönngren's tardiness in notifying it of his new appointments.

Despite the approval, the board imposed a set of limitations that will remain in place for a period of two years effective immediately. The limitations forbid Lönngren to take the following actions:

Taking managerial or executive positions in the pharmceutical  industry

Providing product-related advice on activities within EMA’s remit

Having contact with agency staff or committee members in a professional context

Representing or accompanying third parties at meetings with the agency

By making its decision and supporting documents public, the EMA hopes to ensure accountability and allay the concerns that five European public-health and transparency campaigners raised.

In a press release on Mar. 21, 2011, the EMA Management Board gave its approval for the current activities of former executive director Thomas Lönngren.

EMA Sides with Former Executive Director

Novartis acquired a majority stake in Zhejiang Tianyuan Bio-Pharmaceutical, one of the largest privately held vaccine companies in China. The acquisition gives Novartis an expanded presence in the Chinese vaccine market and will facilitate the introduction of Novartis's vaccines into the country.

"This agreement combines the strength of our vaccines research and development strategy and pipeline with Tianyuan's deep knowledge of the vaccines market in China," said Andrin Oswald, Head of Novartis Vaccines and Diagnostics, in a 

According to the statement, Novartis will collaborate with Tianyuan to strengthen its vaccine portfolio and pipeline, as well as align production processes and quality standards. Novartis also added that it plans to explore new vaccine developments to address unmet medical needs in China.

"We have already identified several joint development programs that could be implemented in China over the next 10 years, with the potential of launching key products responding to unmet medical needs in the mid-term," said Ding Xiaohang, Founder, Chairman and CEO of Tianyuan, in the statement.

In related news, Novartis will eliminate more than 500 positions at its Horsham, United Kingdom site. The full story is available at 

Japan  suspended the use of two pediatric vaccines, one made by Pfizer and one by sanofi, following the deaths of four children in three days. The deaths occurred shortly after vaccination with Pfizer’s Prevenar vaccine (known as Prevnar in the United States) and sanofi’s ActHIB vaccine. Although a panel of experts at Japan’s Health Ministry have found no link between the deaths and vaccination, the suspension will remain in place while further studies are conducted.

Other national regulatory agencies are aware of the situation. In Hong Kong, the Department of Health said in a 

 that it has “no record of untoward event report[s] associated with Prevenar, but we will inform all medical practitioners of the Japanese incident and request them to bring up any anomaly detected." sanofi’s vaccine is not used in Hong Kong, but both are widely used in the US. According to 

, FDA is monitoring the safety of both vaccines, but has not observed any safety concenrs in the US.

This is not the first time that Prevenar has faced safety suspicions. In 2009, a batch of Prevenar was pulled from the market in the Netherlands following the deaths of three infants after vaccination. In 

, however, it was announced that there was no link between the deaths and vaccination.

Japan has suspended the use of two pediatric vaccines made by Pfizer and sanofi following the deaths of four children in three days.