Samsung Bioepis-Biogen’s biosimilar for Lucentis obtains FDA approval

21 September | approvals

The US Food and Drug Administration (FDA) has approved Samsung Bioepis and Biogen’s Byooviz (ranibizumab-nuna), a biosimilar referencing Lucentis (ranibizumab), to treat neovascular (wet) age-related macular degeneration (AMD).

Developed by Samsung Bioepis, Byooviz is also indicated for use in treating macular oedema following retinal vein occlusion (RVO) and myopic choroidal neovascularization (mCNV).

In November last year, the FDA accepted the companies’ biologics licence application to review the use of SB11 as a biosimilar referencing Lucentis.

Biogen will commercialise SB11 under the brand name Byooviz in the US.

Byooviz is an anti-vascular endothelial growth factor (VEGF) treatment. It can avert vision loss in people with retinal vascular disorders, which can lead to permanent blindness or visual impairments in adults.

The companies noted that Byooviz is the first-ever ophthalmology biosimilar to obtain approval in the US.

The FDA based its approval on a totality of data comprising analytical, non-clinical data and clinical data.

21 September | clinical trials


Pfizer and BioNTech have reported positive data from a Phase II/III clinical trial in which a two-dose regimen of their Covid-19 vaccine, Comirnaty, demonstrated strong neutralising antibody responses in children aged five to 11 years.

The messenger ribonucleic acid vaccine is approved by the US FDA as a two-dose schedule to prevent Covid-19 in people aged 16 years or above.

In the initial stage, the Phase I/II/III trial enrolled up to 4,500 children aged six months to 11 years at more than 90 study centres in the US, Finland, Poland and Spain.

It assessed the safety, tolerability and immunogenicity of the two-dose series of the vaccine administered 21 days apart in three age groups, five to 11 years; two to five and six months to two years.

21 September | clinical trials


The Phase III portion of an ongoing Phase II/III trial of Merck and Ridgeback Biotherapeutics’ molnupiravir in mild-to-moderate Covid-19 has enrolled around 1,100 to 1,200 patients of its 1,550-patient target, an investigator said.

The trial could complete enrolment in one to two months, assuming worldwide infection continues to spread at its current rate.

A Merck spokesperson said the trial’s enrolment is on track; November is the company’s best guess for when the trial will have enough events for a final analysis.

The placebo-controlled Phase III MOVe-OUT study has a primary endpoint of percentage of patients who are hospitalised and/or die over 29 days.

20 September | Vaccines


The US FDA advisory committee has voted unanimously in favour of granting emergency use authorization (EUA) to Pfizer and BioNTech’s booster dose of Covid-19 vaccine, Comirnaty, in people aged 65 years and above.

The Vaccines and Related Biological Products Advisory Committee also recommended EUA for the booster shot in certain individuals at increased risk of severe Covid-19.

A third dose of the messenger ribonucleic acid vaccine obtained FDA EUA for use in some immunocompromised people aged a minimum of 12 years.

20 SEPTEMBER | deals


Grifols has entered a share purchase agreement to acquire complete shares of Tiancheng (Germany) Pharmaceutical Holdings for a total of nearly $1.3bn (€1.1bn).

The Grifols and Tiancheng transaction value comprises $906m (€773m) and a loan of $367m (€313m), Grifols noted.

Tiancheng Pharmaceutical owns 89.88% of the ordinary shares and 1.08% of the preferred shares of German public listed healthcare company Biotest.

Biotest focuses on advanced haematology and clinical immunology with a pipeline of new proteins that complement Grifols’ product portfolio.

On concluding the deal, Grifols will indirectly have rights to 17,783,776 ordinary shares in Biotest, signifying nearly 89.88% of Biotest’s voting rights and 44.94% of total share capital.

20 September | approvals


The Korean Ministry of Food and Drug Safety (MFDS) has approved Celltrion Group’s regdanvimab (CT-P59) for extended use in adult and elderly people aged 50 years or above with Covid-19.

Celltrion noted that regdanvimab is the first monoclonal antibody therapy for Covid-19 to obtain full approval from the Korean MFDS.

The antibody treatment is intended for adults with moderate disease symptoms.

Elderly patients with mild symptoms and a minimum of one underlying medical condition such as obesity, cardiovascular disease, chronic lung disease, diabetes, etc and those receiving immunosuppressive agents are eligible for the therapy.

Furthermore, the MFDS has lowered the administration duration for the approved dosage of single intravenous (IV) infusion of 40 mg/kg regdanvimab to 60 minutes from 90 minutes.

In brief

Health Canada grants full approval to Moderna and Pfizer Covid-19 shots

Health Canada has granted full approval to Moderna and Pfizer-BioNTech Covid-19 vaccines, Spikevax (elasomeran mRNA vaccine) and Comirnaty respectively for use in people aged 12 years and above.

This marks the first full approval for Moderna’s Spikevax, which is indicated for active immunisation to prevent Covid-19.

Study identifies possible link between antibiotic use and cancer growth

New research has uncovered a possible link between antibiotic use and the speed of breast cancer growth in mice, and identified an immune cell that could be used to reverse the effect.

Philip Morris International acquires Fertin Pharma for $820m

Philip Morris International has concluded the acquisition of Denmark-based contract development and manufacturing organisation Fertin Pharma from EQT, for an enterprise value of nearly $820m (kr5.1bn).

CinnaGen protein subunit Covid-19 vaccine Phase III results likely within two months

CinnaGen’s Phase III investigation of the protein subunit Covid-19 vaccine SpikoGen will likely have data within the next two months, according to a statement from vaccine developer Nikolai Petrovsky.

US to buy additional doses of Lilly’s Covid-19 antibody therapies

The US Government is to purchase additional doses of Eli Lilly’s neutralising antibody therapies authorised for emergency use to treat Covid-19.

Under the deal, Lilly will deliver 388,000 doses of etesevimab to complement doses of bamlanivimab already purchased by the US Government.

17 September | regulation


The US FDA has updated the EUA for Eli Lilly’s bamlanivimab plus etesevimab to include post-exposure prophylaxis in some people to prevent Covid-19.

Bamlanivimab and etesevimab are indicated to be administered together to treat mild to moderate Covid-19 in adults and children aged 12 years and above who are at high risk of progressing to severe disease.

This neutralising antibody combination is authorised for use as bamlanivimab 700mg and etesevimab 1400mg.

17 September | DEALS


Biocon Biologics, a Biocon subsidiary, has entered a strategic collaboration with Serum Institute of India unit Serum Institute Life Sciences (SILS) for access to and commercialisation of the latter’s vaccine portfolio.

Part of the deal is that Biocon Biologics will offer a nearly 15% stake to SILS, at a post-money valuation of approximately $4.9bn and will gain access to 100 million doses of vaccines each year for 15 years, mainly from SILS’s new vaccine plant in Pune, India.

The alliance will provide Biocon Biologics with commercialisation rights to the SILS vaccine portfolio, which includes Covid-19 vaccines, for worldwide markets.

In brief

MCureX and Samyang sign MoU for mRNA vaccine development

OliX Pharmaceuticals’ subsidiary mCureX has entered a memorandum of understanding (MoU) with Samyang Holdings to develop a messenger ribonucleic acid (mRNA) vaccine for Covid-19.

The companies are co-developing a vaccine that could potentially target Covid-19 viral variants.

Argenx to regain rights to cusatuzumab from Janssen’s Cilag

Janssen Pharmaceutical subsidiary Cilag International has decided to discontinue its partnership and licence agreement with argenx for an investigational CD70-targeting antibody, cusatuzumab.

The development comes after Janssen reviewed all available data linked to cusatuzumab and considered the transforming standard of care for AML treatment.

Serum Institute obtains DCGI nod to produce Sputnik V vaccine in India

The Drug Controller General of India (DCGI) has granted approval to the Serum Institute of India to produce Russia’s Covid-19 vaccine, Sputnik V, in the country.

Based on an adenovirus vector, the vaccine is given in two doses with a gap of 21 days.

FDA updates Regeneron’s Covid-19 antibody EUA to lower dose

The US FDA has updated the EUA for Regeneron Pharmaceuticals’ Covid-19 antibody cocktail, REGEN-COV, reducing the dose to 1,200mg from 2,400mg.

Bristol Myers faces $6.4bn lawsuit over cancer drug delay

UMB Bank, a trustee for Celgene’s former shareholders, has filed a lawsuit against Bristol Myers Squibb for allegedly delaying the development and manufacturing of cancer drug lisocabtagene maraleucel (Liso-cel) to avoid contingent value right payments worth $6.4bn.