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developers to provide data from switching studies to demonstrate interchangeability with a reference biologic in draft guidance published today.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


Trump vows to bring drug production back to US

12-Jan-2017 - President elect Donald Trump has said he will bring drug manufacturing back to the US and introduce bidding measures to cut the amount the country spends on medicines. 

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.

German Merck to build biodevelopment centres in US and China

10-Jan-2017 - Merck has announced plans for process and cell line development centres in the US and China citing biopharmaceutical industry demand for integrated services.

Valeant selling Provenge maker Dendreon to Chinese conglomerate for $820m

10-Jan-2017 - Sanpower Group says Dendreon's in-house manufacturing set-up will remain in place as it looks to increase US and Asian penetration of the prostate cancer cell therapy.

Kite inks Chinese JV and Japanese partnership for lead T Cell candidate

10-Jan-2017 - Kite Pharma has formed a joint venture with Shanghai Fosun Pharmaceutical Industrial Development Company to develop and manufacture its cell therapy axicabtagene ciloleucel in the Chinese market.

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.

US FDA delays Ocrevus decision date asking Roche for more manufacturing data

23-Dec-2016 - The US FDA has pushed back the review date Roche’s Ocrevus (ocrelizumab) after asking for more data on processes used to manufacture the candidate MS treatment.

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.

'One-stop' CRISPR licensing initiative looks to accelerate the technology's benefits

15-Dec-2016 - As the patent war  over CRISPR gene editing technology continues, experts suggest a “one-stop” licensing alternative could help accelerate advances in new medicines.

Emergent secures anthrax vaccine extension with US CDC

09-Dec-2016 - Emergent BioSolutions has signed a $911m (€862m) follow-on contract to supply nearly 30 million doses of its anthrax vaccine to the US Government.

WHO commits to source drugs and vaccines from 'green' suppliers

09-Dec-2016 - The WHO has agreed to source drugs from manufacturers which use sustainable production methods.

JHL and Sanofi plan to sell biosimilars outside China

07-Dec-2016 - Sanofi and JHL Biotech will sell biosimilars in markets outside China in the long term according to the French drug firm.

Sanofi makes play for Chinese biosimilars market in deal with JHL

06-Dec-2016 - Sanofi has teamed with JHL Biotech to develop biosimilar products, including a version of Rituxan (rituximab), for the Chinese and international markets.


Takeda overturns negative EU CHMP opinion for oral drug Ninlaro in ‘face-to-face’ appeal

06-Dec-2016 - Takeda was awarded conditional EU marketing authorisation of the small molecule drug Ninlaro, overturning the EMA’s negative opinion on its efficacy against Multiple Myeloma (MM).

'Make in India' strategy to kickstart domestic biomanufacturing, Biocon

06-Dec-2016 - A lack of investment and government support has stunted biomanufacturing in India, but Biocon says this will change through the country’s 'Make in India' programme.

Bluebird Bio reports positive early safety data from Ph I CAR-T trial

02-Dec-2016 - Bluebird Bio has reported encouraging efficacy and safety data from a Phase I trial of its CAR-T multiple myeloma therapy, bb2121.


Juno deaths: Toxicity is therapy specific, not risk to whole CAR-T field, say experts

30-Nov-2016 - The deaths in a trial of Juno Therapeutics’ JCAR015 are most likely product-specific says the CEO of French CAR-T developer TxCell, who rejected the idea that chemotherapy or the CD19...


Labiotech Refresh: experts talk Juno deaths & orphan drug prices in Paris

29-Nov-2016 - Juno’s CAR T candidate, combatting antimicrobial resistance, and why you should start a biotech in France. Biopharma-Reporter presents the hot topics from last week's 'Labiotech Refresh' event in Paris. ...

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.

Kymab secures $100m and two new Chinese backers

25-Nov-2016 - Antibody developer Kymab has secured $100m from existing backers and new China-based investors Hepalink and ORI Healthcare Fund.

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