SwastiChemEx: biosimilars
Showing posts with label biosimilars. Show all posts
Showing posts with label biosimilars. Show all posts

Sunday, 8 February 2015

Pfizer to acquire Hospira for $17 billion

US based pharma major Pfizer will acquire Hospira - the world’s leading provider of injectable drugs, infusion technologies and biosimilars - for a total enterprise value of approximately $17 billion. Ian Read, chairman and chief executive officer, Pfizer, said, “Hospira’s business aligns well with our new commercial structure and is an excellent strategic fit for our global established pharmaceutical (GEP) business, which will benefit from a significantly enhanced product portfolio in growing markets. Coupled with Pfizer’s global reach, Hospira is expected to drive greater sustainability for our global established pharmaceutical business over the long term."

This strategically complementary combination will add a growing revenue stream and a platform for growth for Pfizer’s GEP business. The expanded portfolio of sterile injectable pharmaceuticals - composed of Hospira’s broad generic sterile injectables product line, including acute care and oncology injectables, with a number of differentiated presentations, as well as its biosimilars portfolio, combined with GEP’s branded sterile injectables, including anti-infectives, anti-inflammatories and cytotoxics - will create a leading global sterile injectables business.

Both sterile injectables and biosimilars are large and growing categories. The global marketplace value for generic sterile injectables is estimated to be $70 billion in 2020. The global marketplace for biosimilars is estimated to be approximately $20 billion in 2020.

The combination also reinforces GEP’s growth strategy to build a broad portfolio of biosimilars in Pfizer’s therapeutic areas of strength through the addition of Hospira’s portfolio that includes several marketed biosimilars. Pfizer will also use its existing commercial capabilities, global scale, scientific expertise and world class development capabilities to significantly expand the reach of Hospira’s products, which are currently distributed primarily in the US, to Europe and key emerging markets, where GEP has a significant presence.

Friday, 13 June 2014

GlobalData shows lucrative biosimilars space

The increasing prevalence of biosimilars will have a noticeably negative impact on the biologics market beyond 2019, despite an initial projected Compound Annual Growth Rate (CAGR) of 8.3%, taking the overall biologics market value from $162 billion in 2013 to more than $262 billion by 2019, says research and consulting firm GlobalData.







The company’s latest report states that patent expirations of branded biologics and the introduction of clearer regulatory frameworks for biosimilars after 2019 will see the latter capturing the market share from biologics.

Joshua Owide, GlobalData’s Director of Healthcare Industry Dynamics, says: “There are a number of factors driving the initiative towards the global adoption of biosimilars, from austerity measures and slow economic growth in the US, to an aging population and increasing demand for healthcare in countries such as Japan.

Monday, 21 April 2014

Hospira recalls seven lots of Propofol injectable emulsion

Hospira, Inc., one of the world's leading provider of injectable drugs and infusion technologies and a global leader in biosimilars, has announced the nationwide recall of seven lots of Propofol injectable emulsion, USP, to the user level due to a glass defect located on the interior neck of the vial, which was identified during a retain sample inspection where the glass vial contained visible embedded metal particulate. Free-floating metal particulates were also identified in vials upon further analysis.

In general, injected particulate matter may result in local inflammation, phlebitis, and/or low level allergic response through mechanical disruption of tissue or immune response to the particulate. Capillaries, which may be as small as the size of a red blood cell, may become occluded. Chronically, following sequestration, particulate matter may lead to granulomatous formation, most likely in the lungs. Long term clinically meaningful impact is low if a patient has normal lung function. While extremely rare, embedded stainless steel may put a patient at risk from MRI (strong magnetic field exposure) as particulate, if in the lung, could potentially dislodge and be pulled through tissue. To date, Hospira has not received reports of any adverse events associated with this issue for these lots.

The affected lots were distributed nationwide to distributors/wholesalers, hospitals and clinics from August 2013 through December 2013. The lot numbers affected by the recall are: Propofol injectable emulsion, 1%, 200 mg / 20 mL (10 mg/mL).

On April 2, 2014, Hospira notified its customers via recall letter that the company had implemented corrective actions to the manufacturing process to prevent recurrence