Biosimilars

South Korea to emerge as global leader in biosimilar R & D

According to the South Korea Pharmaceuticals and Healthcare Report Q2 2010 released by Business Monitor International (BMI) in March 2010, South Korea will emerge as a global leader in biosimilar research and development.

AutekBio to build ‘Asia’s largest biologics contract manufacturing organisation’ in China

AutekBio, Inc. –with headquarters in the Bay Area of California, USA, but operations in China– will build one of Asia’s largest biologic contract manufacturing organisation (CMO) facilities in southern Beijing, China. To construct the facility, AutekBio signed a deal securing US$100 million in venture capital from private and government sources. Contributing to the capital raise were SUMA Ventures and Beijing E-Town Harvest International Capital Management Corporation, Beijing’s Municipal Government’s venture capital group. The new joint venture will build a world class R & D and manufacturing centre in southern Beijing, to service international biologic developments, with combined volumes of bioreactors up to 20,000 L in multiple production lines (trains).

For complex biosimilars in EU: drop clinical comparability

Clinical trials required by European regulators to compare biosimilar products with corresponding biologic brands are surplus to requirements and may even be a barrier for the development of biosimilars of more complicated biologics, state Professor Huub Schellekens and Dr Ellen Moors of Utrecht University, The Netherlands, in a Nature Biotechnology Commentary of January 2010. “If you look in detail at the accepted and rejected biosimilars and the differences, then you might conclude that proof of clinical equivalence is actually overdue,” comments Professor Arnold Vulto of the Erasmus MC, Rotterdam.

New method for producing human-like glycosylated MAbs

As reported online on 28 February 2010 in Nature Chemical Biology, Professor Lai-Xi Wang, Professor Markus Aebi and colleagues describe a new bacterial method for producing homogeneous eukaryotic N-glycoproteins.

GTC achieves high-level production of TG20, a biobetter anti-CD20 MAb with enhanced antibody-dependent cell-mediated cytotoxicity

GTC Biotherapeutics announced on 1 March 2010 that it has achieved high-level production of TG20; an anti-CD20 monoclonal antibody (MAb). The TG20 MAb, which is produced in the milk of transgenic goats, is being co-developed by GTC and LFB as part of an LFB-GTC joint venture.

Glycosylation technologies for biosimilars and ‘biobetters’

According to Mr Hans Baumeister and Mr Steffen Goletz of Glycotope, human cell lines providing a human glycosylation pattern – such as those of Crucell (PER.C6), Cevec (CAP) and Glycotope (GlycoExpress) – have attracted increasing amounts of attention over the past years. In the case of biosimilars, regulatory approval now requires an extensive programme of bioequivalence studies to be undertaken to characterise the product in terms of its biochemical properties, safety and activity. As a consequence, glycosylated biosimilars need to be equipped with a similar pattern of glycosylation. For example, the degree of sialylation should not deviate by more than 20% from that of the original product. Hence, the chosen cell clone with high productivity has to be able to provide post-translational modifications as closely related to the originator’s cell line as possible. However, since glycosylation differs within clones, during the bioequivalence study it is often realised that the product carries different carbohydrates, usually resulting in a hyposialylation; this requires the screening process to be repeated in order to identify a new cell clone that is able to provide the equivalent glycosylation. Several glycosylation analysis technologies are available for the development and production of glycosylated biotherapeutics, applicable to both biosimilars and second-generation ‘biobetters’ (see Table 1).

Biosimilar epoetin zeta gets positive EMA-CHMP opinion for SC route in renal patients in EU

Hospira announced on 22 February 2010 that the EMA’s Committee for Medicinal Products for Human Use (CHMP) has recommended for approval the administration of Retacrit (epoetin zeta) subcutaneously in the nephrology setting. This provides an alternative option to intravenous (IV) delivery of the drug for the symptomatic treatment of anaemia associated with chronic renal failure. Final approval by the European Commission is expected in the next few months, which will result in marketing authorisation for Retacrit subcutaneous (SC) administration in all EU Member States.

Rituximab gets US FDA approval for chronic lymphocytic leukaemia

The US FDA has approved Roche’s Genentech/Biogen Idec's anti-CD20 monoclonal antibody Rituxan/MabThera (rituximab) plus chemotherapy for people with either previously untreated or previously treated (relapsed or refractory) chronic lymphocytic leukaemia (CLL).

As pointed out by Scrip, MabThera was approved in the EU in 2009 for these same indications. However, US approval was held up by a complete response letter issued by the FDA in November 2009. The companies said then that the agency had not requested any new data to complete its review of these applications, but that they were continuing final labelling discussions.

How to tackle overcapacity in monoclonal antibody production

In the early days, most monoclonal antibody (MAb) therapies required high dosages, as pointed out by Ms Gail Dutton in a Genetic Engineering & Biotechnology News Feature Article on 15 February 2010 (see also Monoclonal antibodies modelling - predictive analytics, Improving monoclonal antibody production - antibody-drug conjugate technology and Modern monoclonal antibody production - focus on quality by design, timelines, cost)

Monoclonal antibodies modelling - predictive analytics

Improved analytics is helping to ensure that the active pharmaceutical ingredient (API) quality attributes of monoclonal antibodies (MAbs) are identified as early as possible, determining both the desirable and undesirable characteristics, as pointed out by Ms Gail Dutton in a Genetic Engineering & Biotechnology News Feature Article on 15 February 2010 (see also How to tackle overcapacity in monoclonal antibody production, Improving monoclonal antibody production - antibody-drug conjugate technology and Modern monoclonal antibody production - focus on quality by design, timelines, cost)