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Biosimilars: The next Big thing or Bluster?


Biosimilars are a hot topic for biopharmas with differing regulations, ever changing approval mechanisms and looming patent expiries ensuring they are set to be a continuing subject of debate and discussion. 

Biocon's second fill/finish line at Bangalore site to come online later this year

Mylan and Biocon Neulasta biosimilar to go under US FDA scrutiny

17-Feb-2017 - Biocon’s biomanufacturing facilities in India will need a “meaningful capacity expansion” to cope with long-term global biosimilar demand, the firm says.

Biosimilar group set to lobby new HHS Secretary to reverse reimbursement policy

15-Feb-2017 - Industry group the Biosimilars Forum has welcomed President Trump’s pick of Representative Tom Price as Secretary of Health and Human Services.

Aurobindo building Indian manufacturing plant to support 12 biosimilar pipeline

10-Feb-2017 - Aurobindo’s first biomanufacturing facility will be commissioned this year, the firm said after adding four candidates to its biosimilar pipeline.

Sandoz withdraws Neulasta biosimilar application after EMA questions GMP status

01-Feb-2017 - Sandoz withdrew its pegfilgrastim biosimilar application before responding to concerns about the lack of cGMP accreditation at the candidate’s manufacturing site, the EMA says.

Amgen's two-brand strategy? EU thumbs up for Humira biosimilar duo

31-Jan-2017 - The EMA has recommended approval of two versions of AbbVie’s bestselling biologic Humira (adalimumab), both made by Amgen.

News in brief

EDQM and EMA to clarify how Ph. Eur applies to biosimilars at event next week

31-Jan-2017 - The EDQM and EMA aim to clarify how European Pharmacopoeia (Ph. Eur) monographs apply to biosimilars at an event next week.

Sandoz awaiting facility inspections before filing Humira biosimilar in US

27-Jan-2017 - Capacity upgrades and US FDA discussions delayed the filing of Sandoz’ Humira biosimilar, the company has confirmed.

Biocon wins $68m Malaysian contract for biosimilar insulin and pen supply

26-Jan-2017 - Biocon has been awarded a three-year contract to supply recombinant human insulin formulations made at its Malaysian facility to the country’s Ministry of Health.

Biosimilars could impact US Remicade sales by 15% in 2017, says J&J

25-Jan-2017 - Johnson & Johnson has predicted a 10-15% erosion in sales of Remicade (infliximab) in 2017 following Pfizer’s “at-risk biosimilar launch of Inflectra.”

Boehringer Ingelheim's Humira biosimilar accepted for review in US and Europe

20-Jan-2017 - The EMA and US FDA have agreed to review a candidate Humira (adalimumab) biosimilar developed by Boehringer Ingelheim.

Pfenex, Pfizer and Sandoz hail US FDA interchangeability guidelines

18-Jan-2017 - A clear interchangeability pathway is essential for the US biosimilar market say developers as they begin reviewing the much-welcomed draft FDA guidance.

AbbVie’s Humira IP strategy having ‘chilling effect on competition,’ UK judge

18-Jan-2017 - A UK judge says a vexatious litigation strategy is staving off Humira biosimilars, but AbbVie is “playing by the rules and incurring the costs of doing so,” according to an...

Biosimilar interchangeability

FDA calls for switching studies in draft interchangeability guidelines

17-Jan-2017 - The US FDA expects biosimilar developers to provide data from switching studies to demonstrate interchangeability with a reference biologic in draft guidance published today.

US FDA sticks with four-letter random suffix for biosimilar names

‘Meaningless suffixes’ slammed by industry in FDA naming guidance

13-Jan-2017 - Pfizer and industry groups have criticised the US FDA over the randomness of a four-letter suffix demanded in the nonproprietary names of biological products.

US Herceptin biosimilar one step closer as FDA accepts Mylan BLA

11-Jan-2017 - The US FDA will decide whether to approve Biocon and Mylan’s version of the Roche breast cancer drug Herceptin by the beginning of September.

Teva aiming to be major second and third wave biosimilars company

Teva: ‘Celltrion deal will double biosimilar sales to $600m’

11-Jan-2017 - Celltrion deal and multi-million Euro German plant will make it a major second and third wave biosimilars player says Teva.

US biosimilars will continue to blossom under Trump, say experts

06-Jan-2017 - Trump’s presidency could favour US biosimilars in 2017, but the sector will continue to be hampered by a lack of interchangeability guidance and ongoing litigation, say experts.

US FDA issues final guidance on biosimilarity data use

04-Jan-2017 - The US FDA has published final guidance on the development and use of clinical pharmacology data for drugmakers to demonstrate biosimilarity.

Humira biosimilar developers: can you find who's taking on AbbVie?

23-Dec-2016 - Over 30 companies are looking to compete against Abbvie in the adalimumab space. Can you find them all in our word search?

2016: year of the US biosimilar approval

20-Dec-2016 - With four biosimilars now approved in the US, the sector is growing in confidence says a BMI Research analyst.

Celltrion sets sights on 2017 for EU and US rituximab biosimilar success

25-Nov-2016 - Celltrion is confident that 2017 will bring European approval and a US filing for Truxima, after achieving regulatory success for the Rituxan biosimilar in Korea.

Pfenex: consistently high manufacturing quality key for biosimilar success

15-Nov-2016 - Manufacturing quality is key for biosimilar success says Pfenex, as the US FDA continues to increase its regulatory oversight.

Mylan boasts of 16 biosimilars in portfolio after Mabion rituximab deal

11-Nov-2016 - Mylan has struck a deal to commercialise a version of Roche’s Mabthera in Europe made by Polish biotech Mabion using a 2,500L disposable bioreactor system.

Coherus' Humira formulation patent challenge rejected by PTAB

09-Nov-2016 - The rejection of a petition against a Humira formulation patent is problematic for Coherus but may not affect other adalimumab biosimilar developers, an analyst says.

Mylan targets US Herceptin market with FDA biosimilar submission

08-Nov-2016 - A Herceptin (trastuzumab) biosimilar developed by Mylan and Biocon has been submitted to the US FDA.

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