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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. 

EMA committee gives Samsung Bioepis nod for Humira biosimilar Imraldi

23-Jun-2017 - The EMA has recommended the approval of Samsung Bioepis’ adalimumab biosimilar, placing the firm on the brink of having three anti-TNF inhibitors in Europe.

Brazilian plant to make Humira biosimilar in 'tobacco-based bioreactors'

21-Jun-2017 - A tobacco plant-based platform could make monoclonal antibodies up to 90% cheaper than mammalian systems, says Axis Biotec which is building a pilot plant in Brazil.

J&J confident of retaining Remicade rewards as biosimilar clouds gather

31-May-2017 - Bestselling biologic Remicade (infliximab) will remain a multi-billion dollar product for J&J for at least the next five years, even with biosimilar competition the firm says.

Second time the charm for Pfizer’s Epogen biosimilar in US

30-May-2017 - An advisory committee has recommended approval of Retacrit in the US after Pfizer addressed manufacturing and clinical concerns from its first submission in 2015.

Dr Reddy’s turns to single-use for biosimilar production in India

19-May-2017 - Dr Reddy’s will expand its biosimilar manufacturing capacity in Hyderabad by 4,000L using GE Healthcare’s FlexFactory platform based on single-use technologies.

Seven-year switch? Formycon bets on third wave biosimilars with Stelara candidate

12-May-2017 - Formycon says it is aiming to bring the first biosimilar of J&J’s immunology best-seller Stelara (ustekinumab) to market as early as 2023 in the US.

Biosimilars in Europe: 11 years, 28 approvals, 0 safety concerns

10-May-2017 - The EMA has not experienced any concerns with the safety of the 28 biosimilar products it has recommended, according to an information guide published for healthcare professionals.

US biosimilars: Quality trumps manufacturing location, say physicians

11-Apr-2017 - American-made biosimilars hold no advantage in the US market according to patient and physician groups which place emphasis on trusted and reputable manufacturers instead.

Amgen targets Roche in Europe with Herceptin biosimilar submission

22-Mar-2017 - Amgen has signalled its intention to take a share of the $6.9bn Herceptin market by filing its trastuzumab candidate in the EU.


Biosimilar interchangeability: Do you know your switching from your substitution?

21-Mar-2017 - US FDA interchangeability guidance adds another level of confusion over the concept of biosimilar switching, says Medicines for Europe.

FDA grants industry requests for interchangeability guidance comment extension

15-Mar-2017 - The US FDA has extended the comment period for its draft biosimilar interchangeability guidance until May 19.

Biosimilars were ‘plan B,’ says portfolio pumped Merck KGaA

10-Mar-2017 - Germany's Merck has confirmed it is divesting its biosimilars division in order to concentrate on its innovative product pipeline.


Roche tops biosimilar defence league by a 'country mile'

08-Mar-2017 - Roche is better positioned than Amgen, AbbVie and Janssen to defend against biosimilar competition, according to this writer and a Twitter poll.

UK High Court rules against AbbVie in Humira indication patent battle

07-Mar-2017 - Biosimilar developers have welcomed a court ruling against AbbVie regarding Humira indication patents, but an IP lawyer warns the judgement is not binding outside the UK.

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.

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