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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. 

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developers to provide data from switching studies to demonstrate interchangeability with a reference biologic in draft guidance published today.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.

Biocon Malaysia insulin plant set to supply Lantus biosimilar under EU review

04-Nov-2016 - Biocon says it is well-positioned to up production of its Lantus biosimilar after the insulin glargine – co-developed with Mylan – was accepted for review in the EU.

Sale speculation: We assess German Merck's biosimilar business

04-Nov-2016 - Germany’s Merck has refused to comment on rumours it is looking to sell its biosimilars business, but what would a hypothetical buyer actually get?

Amgen ‘unlikely’ to launch Humira biosimilar in 2017 due to AbbVie lawsuits

01-Nov-2016 - Amgen has indicated it will not launch its approved biosimilar of Humira (adalimumab) until litigation battles with AbbVie are settled.


Bio-synonyms: describing biosimilars without saying ‘copycats’ or ‘knock-offs’

21-Oct-2016 - Terms such as ‘copycats’ and ‘knock-offs’ are inaccurate and misleading, say drugmakers. We ask therefore how industry and the media should refer to biosimilar products?

Remsima and Inflectra not inferior to Remicade, NOR-SWITCH study finds

18-Oct-2016 - A two year-long Phase IV study has shown Celltrion’s infliximab biosimilar is not inferior to its originator Remicade, but a physician group still urges caution when switching.

Pfizer: US Remicade biosimilar will launch at 15% discount in November

18-Oct-2016 - Pfizer’s Inflectra will become the first monoclonal antibody biosimilar available in the US when it is launched next month.

Biosimilar interchangeability: what’s the big deal, asks CPhI delegates?

12-Oct-2016 - Long-awaited interchangeability guidance will strengthen the public’s confidence in biosimilars, but is likely to only affect 20% of all biological products, MedImmune and Biocon said at CPhI.

Teva bolsters its biosimilar business through $160m deal with Celltrion

11-Oct-2016 - Teva has partnered with Celltrion to commercialise versions of Roche’s Herceptin and Rituxan, helping fill a gap in its second wave biosimilars pipeline.

Samsung Bioepis Herceptin biosimilar accepted for review in EU

04-Oct-2016 - The EMA will assess a version of Roche’s breast cancer drug Herceptin (trastuzumab), the fifth biosimilar candidate submitted for review by Samsung Bioepis.


Brand biosimilar: does Amjevita give away Amgen's biologics strategy?

28-Sep-2016 - Biosimilar makers have been vocal about product names not differentiating from their reference biologics, so why does the newly-approved Humira copy appear to reference its sponsor, Amgen?

Shire takes axe to biosimilars post-Baxalta merger

28-Sep-2016 - Shire has reinforced its focus on rare diseases by exiting Baxalta's Humira and Enbrel biosimilar programmes with Momenta and Coherus.

The end for AbbVie’s bestseller? US FDA approves Amgen’s Humira biosimilar

26-Sep-2016 - Amid ongoing patent litigation, the FDA has approved Amgen’s Amjevita: the first US biosimilar version of AbbVie’s top selling rheumatoid arthritis biologic Humira.

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