Biosimilars and Biobetters

Cipla has launched the first biosimilar of etanercept in India for the treatment of rheumatoid disorders. The product will be marketed under the brand name Etacept. The launch of Etacept marks Cipla's entry into the biologics market, offering a low-cost alternative to Pfizer and Amgen's rheumatic disorder blockbuster Enbrel in India.

Maryland is the latest state to consider whether to include additional requirements for substitution of biological products

Teva and Lonza have announced that their joint venture will continue to develop, manufacture and market affordable, efficacious and safe biosimilars.

Sound policies are needed to govern the substitution of interchangeable biologics.

Merck and Samsung Bioepis have formed an agreement to develop and commercialize multiple prespecified and undisclosed biosimilar candidates.

Manufacturing and in-depth characterization provide basis for demonstrating product equivalence.

The European Medicines Agency has added granularity to its biosimilars approval pathway by releasing a guideline on biosimilar monoclonal antibodies (mAbs).

AET BioTech and BioXpress Therapeutics have entered into an agreement to codevelop a biosimilar version of Abbott's tumor necrosis factor inhibitor monoclonal antibody adalimumab.

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

An examination of the current and projected market for biosimilars, development costs for biosimilars compared with small-molecule generic drug, and partnerships in biosimilars.

Dr. Reddy's Laboratories and Merck Serono, a division of Merck KGaA, have partnered to codevelop a portfolio of biosimilar compounds in oncology.

Extensive physicochemical characterization of the innovator product and the proposed biosimilar provides the foundation for demonstrating biosimilarity.

Does global development have to entail multiple comparability studies?

Coherus BioSciences, Daiichi Sankyo Form Biosimilar Pact; Sandoz Agrees to Acquire Fougera Pharmaceuticals; and More.

AstraZeneca's CEO David Brennan To Retire; PRA, Amgen Reach New Biosimilar Agreement; and More.

On Mar. 29, 2012, the Generic Pharmaceutical Association reiterated its call for Congress to move forward with user-fee proposals for generic drugs and biosimilar products.

AstraZeneca Files Suit Against FDA; Pfizer, Biocon Terminate Biosimilar Alliance; and More.

BASi Restructures; Celerion, Ricerca Biosciences Form Biosimilars Alliance; and More.

Has the long-awaited guidance answered all of the industry's questions?

JHS Secures Four Sterile Parenteral Products Manufacturing Contracts; Samsung Biologics, Biogen Idec Establish Biosimilars Joint Venture; and More.

Samsung and Biogen Idec agreed to invest $300 million to establish a joint venture to develop, manufacture, and market biosimilars. The deal is Samsung's latest effort to strengthen its position in biosimilars.

On Dec. 6, 2011, FDA announced that a public meeting will be held on Dec. 16, 2011 to discuss recommendations for a user fee program for biosimilar biological products for fiscal years 2013–2017.

Biosimilar manufacturers need better expression systems and analytical tools to compete.

Biosimilar manufacturers need better expression systems and analytical tools to compete.

EMA released two concept papers for consultation that address the need to revise existing guidelines on biosimilar medicines and influenza vaccines.

Using information technology tools to enhance process understanding helps reduce variability that can affect speed to market.

Since the passage of the BPCI Act in 2009, manufacturers have been waiting for guidance from FDA on what that approval process will look like.

Are biosimilars the next big thing or just the next big bubble?

Follow-on versions of complex biologics require extensive expertise in development and regulatory procedures.

Merck and Hanwha Chemical have formed an exclusive global agreement to develop and a commercialize a biosimilar of Enbrel, a drug to treat moderate to severe plaque psoriasis, psoriatic arthritis, and moderate to severe rheumatoid arthritis.