Biocon surgest 15% on USFDA approval

Mylan and Biocon are among a host of biosim developers that are working to grab a piece of Roche’s global cancer fortunes

Biocon surged 14% to Rs 510, also its all-time high on the BSE in early morning trade, after the company said it has secured a regulatory approval to market a biosimilar for anti- cancer drug Herceptin in the US.

The biosimilar - developed by Mylan and Biocon and called Ogivri (trastuzumab-dkst) - has been approved by the FDA for HER2-positive breast or metastatic stomach cancer, the same indications as Herceptin which brought in nearly $7bn in sales previous year, around $2.5bn of that total from the U.S. market. Mylan and Biocon's biosimilar is called Ogivri (trastuzumab-dkst) and follows a back and forth of delays with regulators over manufacturing issues at a plant in India. Mylan is a global leader in the development and manufacturing of complex products, including biosimilar medicines, with a portfolio of 16 biosimilar and insulin analog products.

Scott Gottlieb, FDA Commissioner (MD, USA), concluded: "The FDA continues to grow the number of biosimilar approvals, helping to promote competition that can lower health care costs".

Ogivri's clearance is based on a review of evidence that included extensive structural and functional characterisation, animal study data, human pharmacokinetic and pharmacodynamic data, clinical immunogenicity data and other clinical safety and effectiveness data that demonstrates its biosimilarity to Herceptin (trastuzumab).

After this review, Ogivri was approved as a biosimilar and not as an interchangeable product.

But Ogivri also shares Herceptin's side effects, which can include heart disease (cardiomyopathy), infusion reactions, and lung damage, and it may also harm a developing fetus.

"We are extremely pleased with the acceptance of our [marketing authorization application in Europe]", Rajiv Malik, Mylan's president, said in a press release.

Related News:

  • Ingress game getting a revamp next year

    Ingress game getting a revamp next year

    So basically this is huge news for people who stuck with Ingress even if Niantic was busy building up Pokemon GO . The game has been downloaded over 20 million times since its launch in 2012.
    High wind warning issued for Santa Clarita Valley

    High wind warning issued for Santa Clarita Valley

    Humidity levels will be in the 10 to 15 percent range today and the 7 to 15 percent range from Tuesday through Saturday. The mountains in Ventura County are also under a red flag warning.
    UGA will play Oklahoma in the College Football Playoff

    UGA will play Oklahoma in the College Football Playoff

    Georgia is making its 21st consecutive bowl appearance, which ranks as the third longest active streak in the country. Mayfield has completed 71 percent of his passes for 4,340 yards, 41 touchdowns and five interceptions this season.
  • Max hospital row: Two doctors who declared premature baby dead terminated

    Max hospital row: Two doctors who declared premature baby dead terminated

    Cops are also probing Ashish's allegation that the hospital had asked them to pay Rs 50 lakh for keeping the baby in its nursery. The family observed slight movement in the polythene bag while they were on their way to perform the last rites.
    Ex-Yemeni president Saleh killed by allies

    Ex-Yemeni president Saleh killed by allies

    He added, "The conspiracy of betrayal and treason failed, this black day for the forces of the aggression". The official spoke on condition of anonymity because he wasn't authorized to speak to the press.
    NJ sports betting case: How we got here and what happens next

    NJ sports betting case: How we got here and what happens next

    In this November 30, 2017, photo, betting slips are seen on a table at the Monmouth Park racetrack in West Long Branch, N.J. In 2014, New Jersey tried a different tactic by repealing laws prohibiting sports gambling at casinos and racetracks.
  • Saudi-Led Coalition Provides Air Support for Yemen's Saleh

    Saudi-Led Coalition Provides Air Support for Yemen's Saleh

    But in recent months, the alliance frayed amid Houthi suspicions Saleh was leaning toward the Saudi-led coalition backing Hadi. The breakdown of the alliance has led the coalition to step up its bombing of Houthi positions, in support of Saleh's forces.
    Jose Mourinho Pondering Luke Shaw Start Against CSKA Moscow

    Jose Mourinho Pondering Luke Shaw Start Against CSKA Moscow

    The defender has been eased in by Jose Mourinho since his £31 million move from Benfica in the summer. Shaw has had a troubled time of things since joining Manchester United in 2014 from Southampton.
    Director Bryan Singer departs Queen biopic mid-production

    Director Bryan Singer departs Queen biopic mid-production

    Robot star, 36, reportedly complained to Twentieth Century Fox about Singer's "unreliability and unprofessionalism". THR remarks Singer's extended absence as the "final straw" for the studio, which led to his termination today.
  • Facebook to create 800 new jobs in London

    Facebook to create 800 new jobs in London

    Facebook has unveiled its new office in Central London, 10 years after the social media company first came to the UK. The building has been created to house both engineers and developers along with Facebook's marking and sales teams.
    Manafort Broke Gag Order, Ghost Wrote Op-Ed With Kremlin Connected Colleague

    Manafort Broke Gag Order, Ghost Wrote Op-Ed With Kremlin Connected Colleague

    Manafort/Gates allegations have nothing to with those alleged ties, however. Manafort and Gates pleaded not guilty to the charges.
    ABC suspends journalist over inaccurate Flynn reporting

    ABC suspends journalist over inaccurate Flynn reporting

    Behar read the false report on air, prompting her audience to break into uproarious applause, which co-host Meghan McCain compared to Oprah's now famous vehicle giveaway.


Most liked

LaVar Ball pulls Lonzo Ball's brother LiAngelo Ball from UCLA
So what's next for LiAngelo Ball? This is not an ideal situation since he isn't expected to be drafted. And his latest move has him pulling another one of his sons from school.

CME Group sets date for Bitcoin futures launch
One bitcoin was worth just a fraction of a penny when it started trading in 2010, and by the start of this year was worth $1,000. Nasdaq Inc also plans to list a futures contract based on bitcoin in 2018, Reuters reported last week.

Google adds more browsing security to your Android device
The OS maker is giving app developers 60 days to fix their issues and update apps with notifications of their full practices. Google's Safe Browsing team is tamping down on "unwanted and harmful" mobile activity on Android, Google said on Friday.

US Defence Secy Mattis arrives in Pak
John Nicholson, the top US commander in Afghanistan, said there have been no changes in Pakistan's support for militant networks. He said the USA has been direct about its expectations from Pakistan. "We're hoping to see those changes", he said.

Capcom Finally Announces Mega Man 11 For Modern Platforms
Mega Man Legacy Collection and Mega Man Legacy Collection 2 will release for Nintendo Switch worldwide in Spring 2018. Either way, though, it's the most love the series has gotten since X8 came out for the PS2 more than a decade ago.

Patriots' Gronkowski gets one-game suspension for late hit
Zolak thought that White was holding on the play and that somehow excused Gronkowski's retaliation. It was unclear what McDermott said to Belichick to elicit that response from the Patriots coach.

Voyager 1 investigation fires quiescent thrusters in interstellar space
NASA scientists and propulsion experts weren't also sure if the thrusters would work in short bursts, if they worked at all. The aging spacecraft, first launched in 1977, is the fastest and most well-traveled spacecraft ever launched by NASA .

Facebook unveils Messenger app for kids
Peggy's parents will then have to approve your contact request in order to ass your child to Peggy's contact list as well. Facebook's child-friendly venture comes as other tech companies like YouTube struggle with kid content on their platform.

Meek Mill denied bail, judge labels him a 'danger to the community'
The appeals charge that the judge has made the case personal and has wrongly assumed an "essentially prosecutorial" role. This interaction occurred in the judge's chambers, and a transcript is unavailable.

Elton John announces his mother's death, says he's 'in shock'
Fans and celebrities offered their condolences including singer and actress Betty Buckley who offered her condolences. This past Mother's Day, he tweeted a photo posing with her that was captioned, " Dear Mum, Happy Mother's Day! ".

Amazon officially launches in Australia today
Kindle e-readers are on sale, from the cheapest at $109 to the Kindle Paperwhite from $179 and the all-new Kindle Oasis from $389. Amazon has said that "customers can enjoy free delivery on eligible orders above $49 that are sold by Amazon ".

Words make friends: Young rapper meets elderly gaming partner for first time
And finally, last week, the unlikely duo got to meet in person in Florida after a pastor coordinated their meeting. Spencer said he and Roz were randomly paired by the game and they went on to play more than 300 games together.

Shohei Ohtani reportedly narrows choice of MLB teams to five
Ohtani is limited to a minor league contract because of restrictions imposed by the MLB collective bargaining agreement. The bitter Yankees fan in me hopes Ohtani signs with the Padres so that he becomes absolutely irrelevant.

Huskies to play Penn State in the Fiesta Bowl
This is very much a possibility, as it has been proven by Bryce Love and Stanford that Washington can be beaten on the ground. This is the fourth straight year in a row the Nittany Lions are playing in a bowl game under Coach James Franklin .

Former Boston Symphony Orchestra Conductor Being Investigated for Sexual Abuse
He said he was reaching out to police in Lake Forest because some of his encounters with Levine took place there in the mid-1980s. On Sunday, the BSO released a statement that said it did not know about the allegations against Levine before Saturday.